<h3>Job Description</h3>
Job Description
Validation &amp; Engineering Group, Inc. (V&amp;EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
<ul>
<li>CQV Specialist for Upstream Process Equipment</li>
</ul>
The CQV Specialist for Upstream Process Equipment will be responsible for the commissioning and qualification of systems supporting cell culture operations in a cGMP biotechnology manufacturing environment. The role includes the development and execution of protocols for bioreactors, media preparation systems, and other upstream support utilities. The successful candidate will collaborate with cross-functional teams and ensure compliance with FDA, EMA, and ICH regulatory requirements throughout the CQV lifecycle.
Key Responsibilities:
<ul>
<li>Author, review, and execute commissioning and qualification protocols (IQ, OQ, PQ) for upstream equipment.</li>
<li>Perform field inspections, verification activities, and system walkdowns.</li>
<li>Support FAT/SAT execution with equipment vendors and engineering teams.</li>
<li>Ensure systems are installed, configured, and performing according to URS, FS, and DS documentation.</li>
<li>Troubleshoot equipment and resolve discrepancies or deviations during commissioning and qualification.</li>
<li>Maintain traceability between user requirements, functional/design specifications, and testing protocols.</li>
<li>Interface with automation, process engineering, QA, and manufacturing to drive schedule adherence and quality.</li>
<li>Prepare and review summary reports, risk assessments, and impact assessments as part of the validation package.</li>
</ul>
Upstream Equipment in Scope:
<ul>
<li>Single-use and stainless-steel bioreactors (SUB/SSB).</li>
<li>Media preparation tanks and skids.</li>
<li>Cell culture incubators.</li>
<li>Control systems for temperature, pH, DO, agitation, and gas flow.</li>
<li>Seed train and expansion vessels.</li>
<li>Sterile filtration skids.</li>
<li>Clean utilities interfacing with process systems (WFI, clean steam, process air).</li>
</ul>
Qualifications:
<ul>
<li>Bachelor’s degree in engineering, biotechnology, or related science field.</li>
<li>3–7 years of CQV experience in a biopharma GMP environment, with specific focus on upstream process systems.</li>
<li>Proficiency in authoring and executing validation protocols, and working within electronic systems (e.g., Valgenesis, Kneat).</li>
<li>Familiarity with industry regulations including FDA, EMA, ICH Q8–Q10, and ASTM E2500.</li>
<li>Strong technical understanding of upstream biotechnology processes and associated automation platforms.</li>
</ul>
Preferred Skills:
<ul>
<li>Experience with single-use technology (e.g., Sartorius, Thermo Fisher, Pall).</li>
<li>Working knowledge of DeltaV or other process control systems.</li>
<li>Exposure to tech transfer or facility startup projects in GMP settings.</li>
</ul>

Validation Specialist (Upstream Process Equipment) LL04-250822

<h3>Job Description</h3>
Job DescriptionOur Fortune 500 Medical Device client has an exciting opportunity for a Supplier Engineer I. Job Summary: Provides leadership, projects management, and drives onboarding of metals components within the Watchman, Interventional Cardiology and Peripheral Intervention Rhythm Management, NMD and Electrophysiology divisions owned by the Supplier Engineering department. This individual works independently, serves as a leader for projects and interacts cross functionally to execute deliverables according to business needs. He/she is refining, broadening, and applying scientific expertise within and across disciplines surrounding core business principles. Key Responsibilities: • Builds partnerships and ensure quality and regulations compliance by working with suppliers around the globe to understand requirements, influence, plan, schedule, conduct and coordinate detailed phases of the engineering work to achieve supplier compliance and meet project milestones. • Identifies and leads VIPs (Value Improvement Projects) and cost optimizations within our supply chain • Partner with PMOs from different divisions to support supplier engineering action items • Executes plans to support supply chain objectives; supplier performance, supplied material risk mitigation and execution of materials VIP. Proficient in the use of all business tools • Leads and/or participates in project teams coordinating the efforts of engineers and cross functional team members to qualify and improve supplier processes. • Drives troubleshooting processes and problem-solving methodologies at supplier facilities to drive quality, reliability, and supply chain improvements. • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. • Supports supplier engineers with acquisition and sustaining projects which may include qualification, supplier change assessments, and restricted material evaluations. Quality Systems Duties and Responsibilities: Build Quality into all aspects of their work by maintaining compliance to all quality requirements. Required Qualifications: • Degree in Engineering, with 1+ of experience • Excellent communication and project management skills are a must • Strong bias for action and results orientation is critical • Individual must be self-driven and self-motivated to learn and use that knowledge to produce results • Good understanding of statistical methods, six sigma methodologies, and problem-solving methodologies. Preferred: Some engineering experience Some previous experience working with Suppliers Other Details: Schedule: 08:00:AM - 04:30:PM Work Setup: Onsite — Maple Grove, MN Contract Length: 6 Months (11/10/2025 - 5/8/2026) with Possible Extension

Supplier Engineer I -- Medical Device (Onsite -- Maple Grove, MN) Contract with Possible Extension

<h3>Job Description</h3>
Job DescriptionASR is seeking an experienced Instrumentation Technician for an exciting opportunity working The Instrumentation Technician will support the 59 TES Flight Test Data Center (FTDC) in the planning, development, modification, troubleshooting, and maintenance of advanced airborne instrumentation systems for fighter aircraft including F-15E, F-16, F-22, and F-35. This role is critical to ensuring mission readiness and successful data collection for operational test missions. Responsibilities: 
<ul>
<li>Develop, integrate, and maintain one-of-a-kind airborne instrumentation systems.</li>
<li>Perform calibration and troubleshooting of systems including video and digital data recording, telemetry, and weapon function monitoring.</li>
<li>Operate and maintain electronic test equipment such as oscilloscopes, logic analyzers, spectrum analyzers, and power supplies.</li>
<li>Conduct system functional checkouts, cockpit integrity checks, data uploads/downloads, and mission configurations.</li>
<li>Coordinate instrumentation requirements and schedules with Operations and Aircraft Maintenance Units.</li>
<li>Interpret technical data including schematics, blueprints, and specifications.</li>
<li>Provide technical leadership and mentorship to junior technicians.</li>
<li>Support post-mission data analysis and ensure compatibility with data reduction systems.</li>
<li>Assist in the movement, storage, and loading of instrumentation systems.</li>
<li>Participate in flightline maintenance operations and additional duties as assigned (e.g., COMSEC, QA Augmentee, HAZMAT).</li>
</ul>
 Qualifications:
<ul>
<li>Level I: 2+ years of aircraft instrumentation experience.</li>
<li>Level II: 5+ years of aircraft instrumentation experience.</li>
<li>Level III: 10+ years of aircraft instrumentation experience.</li>
<li>Practical knowledge of electronic principles and aerospace instrumentation systems.</li>
<li>Ability to work in a fast-paced, mission-critical environment with minimal supervision.</li>
<li>Strong communication and coordination skills across multidisciplinary teams.</li>
<li>Experience with instrumentation systems such as QRIP, DART/eDART, RTAS, GLite, CRIIS, ADAP, ARIP, AARI, FCR, HSDR.&nbsp;&nbsp;(Preferred)</li>
<li>Familiarity with T-2 aircraft modifications and operational testing environments.&nbsp;&nbsp;(Preferred)</li>
<li>Prior military or DoD contractor experience in flight test instrumentation.</li>
<li>Secret to Top Secret clearance with SCI eligibility.</li>
</ul>
 ASR offers a comprehensive benefits package which includes Holidays, Paid Time Off and Sick Days, Health Insurance (medical, dental and vision); and a 401(k) plan. &nbsp;
About ASR International
ASR provides world-wide Management and Technical Support Services to Government agencies and Fortune 500 customers. Founded in 1986 and headquartered in Long Island, NY, ASR serves its clients with a full spectrum of complex professional and technical support services including Construction Management, Engineering, Logistics, Project Management and Quality Control across the U.S. and in more than 40 countries worldwide.
Benefits
Hired applicants may be eligible for benefits, including but not limited to, an excellent compensation package and comprehensive benefits package which include a flexible work schedule, Paid Holidays, Paid Time Off and Sick Days, Health Insurance (medical, dental and vision); and a 401(k) plan.
The salary range provided for this role is a good faith estimate representative of all experience levels. ASR considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate’s work experience, location, education/training, and key skills.
This job description is intended to describe the general nature and level of work performed by people assigned to this job description. The job description is not intended to be an exhaustive list of responsibilities, duties and skills required for this position. Please note that your resume and candidacy may be subject to customer approval, acceptance and clearing of the required background check and successfully obtaining and maintaining any required security clearances, if any.
ASR is committed to the policy of equal employment opportunity. In order to provide equal employment and advancement opportunities to all individuals, employment and promotion decisions at ASR are based on merit, qualifications, and abilities. ASR’s hiring and employment practices are not influenced or affected by an applicant’s or employee’s race, color, religion, sex, national origin, age, veteran status, marital status, ancestry, ethnicity, physical or mental handicap / disability which is unrelated to job performance, sexual orientation or any other characteristic / classification protected by law. 
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Instrumentation Technician

<h3>Job Description</h3>
Job Description
BOOST LLC is a dynamic management consulting firm that offers an array of government-compliant back-office solutions to support our teaming partners within the GovCon space. We are working with our client, Don Selvy Enterprises to find their next highly skilled RF Engineer.
About DSE DSE, Inc. is a team of experienced professionals dedicated to engineering, training and program management to enable front-line soldiers, sailors and Marines to fully exploit the tactical capabilities of aviation and maritime platforms. We accomplish this by using the most qualified employees and keeping abreast of every new capability in aviation, maritime technologies and simulation/training technology as it emerges. We are dedicated to providing the best technical counsel, the latest technology trends, and the best qualifications in the industry.
Our wide range of expertise is constantly expanding as we seek valued members of the DSE team and work to develop each of them to their fullest potential in the field. To this day, DSE continues to foster a work environment that supports ingenuity and the care for each member of the team.
Position Summary Seeking an RF Engineer to support the U.S. Marine Corps’ MAGTF Agile Network Gateway Link (MANGL) program. Responsibilities include RF hardware/software design, waveform development, IP networking, and integration of tactical radios and data links. The role involves ensuring EMC compliance, supporting CSfC solutions, and contributing to system architecture, requirements management, and cross-domain communication systems. The engineer will also support acquisition documentation efforts and provide technical continuity for the Digital Interoperability team, working closely with stakeholders and joint partners.
Responsibilities • Support the Digital Interoperability (DI) Marine Air Ground Task Force (MAGTF) Agile Network Gateway Link (MANGL) family of systems • Perform systems engineering, hardware and software design and support, and RF system integration • Apply electromagnetic compatibility (EMC) engineering practices to ensure compliance • Develop and support Internet Protocol (IP) networking, data links, and tactical radio networks • Contribute to waveform development and integration efforts • Support Commercial Solutions for Classified (CSfC) initiatives • Conduct architecture development and requirements management • Develop and maintain software and firmware components, including system-level software support • Provide support for specialized mission systems and hardware design • Deliver analytical support and continuity for the U.S. Marine Corps Digital Interoperability team • Lead and contribute to technical discussions and presentations with MANGL stakeholders, cross-service, and joint partners • Support the MANGL Integrated Product Team (IPT) by: • Developing, editing, and producing Acquisition documentation in alignment with the acquisition strategy • Supporting both Middle Tier Acquisition Rapid Prototype and initial fielding efforts • Ensuring compliance with the Acquisition Plan’s required documentation list
Required Education
• Bachelor of Science Degree or greater in Electrical Engineering. A four-year ABET accredited Engineering Degree is preferred.
Required Experience • Minimum of ten (10) years of experience in an Engineering role. • Experience in hardware/software development, modeling, simulation, and system test and evaluation • Extensive background in waveform development and deployment across multiple tactical radio platforms • Skilled in designing system protocols, including: o Radio Frequency Identification Device (RFID) o Wi-Fi o Traffic routing and message translation o Database hosting and software support for end-user devices o Gateway process development o Dual-domain subsystem and cross-domain solutions o Data-at-rest encryption
 This position is 100% onsite at Naval Air Station Patuxent River, located on the Chesapeake Bay in St. Mary's County, Maryland, quarterly.
Must be able to obtain and maintain a Secret security clearance. Due to the sensitivity of customer related requirements, U.S. Citizenship is required.
Starting salary range between $130,000 to $165,000 annually. 
DSE is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

RF Engineer

<h3>Job Description</h3>
Job Description
 About Us
At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences industry. Our team works with clients to ensure their facilities, equipment, and processes meet regulatory standards, enabling the safe and efficient production of pharmaceuticals. cGMP Consulting is based in Lake Forest, IL. Our main client locations are Melrose Park, IL, North Chicago, IL, Waukegan, IL and Pleasant Prairie, WI.&nbsp;
Position Summary
cGMP Consulting is seeking a motivated and detail-oriented individual to support the execution of engineering activities for equipment, utilities, facilities, systems, and processes. This entry-level role offers the opportunity to gain hands-on experience in a dynamic, GMP-compliant manufacturing environment.&nbsp;
The ideal candidate will excel in critical thinking, technical writing, and protocol execution while demonstrating the ability to work with limited supervision. This candidate should have a basic understand of current Good Manufacturing Practices (cGMP) and FDA regulations and guidelines.&nbsp;
Responsibilities&nbsp;
The essential functions include, but are not limited to the following:&nbsp;
<ul>
<li>Assist in the setup, testing, and daily operation of new processes, equipment and systems in collaboration with Engineering teams.&nbsp;</li>
<li>Perform validation and qualification tasks for equipment, utilities, cleaning procedures, computer systems, and/or new products.&nbsp;</li>
<li>Execute validation/qualification studies for utilities, equipment, cleaning processes, computer systems, and new products, including protocol preparation and final report documentation.&nbsp;</li>
<li>Support deviation investigations by collecting data, writing reports, and performing supplemental qualification activities.&nbsp;</li>
<li>Author SOP updates and revisions related to processes, equipment and system modifications.&nbsp;</li>
<li>Operate and program instruments (e.g., temperature/humidity dataloggers) for controlled temperature/humidity chamber qualifications (e.g., lyophilizers, warehouses, sterilizers, incubators).&nbsp;</li>
<li>Collaborate with SMEs to identify and resolve technical challenges effectively.&nbsp;</li>
<li>Maintain compliance with company policies, cGMPs, regulatory requirements, and safety protocols.&nbsp;</li>
<li>Utilize tools such as Word, Excel, and electronic document management systems to complete tasks efficiently.&nbsp;</li>
<li>Perform additional tasks as assigned by management.&nbsp;</li>
</ul>
Requirements&nbsp;
<ul>
<li>Bachelors’ degree in Engineering, Science, or a related field of study.&nbsp;</li>
<li>0-2 years’ experience in a GMP manufacturing environment.&nbsp;</li>
<li>Experience in technical writing including drafting standard operating procedures, protocols, and/or reports is preferred.&nbsp;</li>
<li>Familiar with regulatory (FDA) requirements.&nbsp;</li>
<li>Business minor or coursework is strongly encouraged.&nbsp;</li>
<li>Advanced critical thinking and technical writing skills.</li>
<li>Strong organizational, communication, and interpersonal skills.&nbsp;</li>
</ul>
Compensation and Benefits&nbsp;
<ul>
<li>Expected pay range per year: $65,000-$85,000 USD&nbsp;</li>
<li>Expected benefits include: Medical, Dental, Vision, PTO, 401K&nbsp;</li>
</ul>
Disclaimer&nbsp;
The duties and responsibilities described are not a comprehensive list and additional tasks may be assigned to the employee from time to time; or the scope of the job may change as necessitated by business demands. All duties and responsibilities are subject to possible modification to reasonably accommodate individuals with disabilities. The requirements listed are the minimum levels of knowledge, skills, or abilities necessary to perform this job successfully. The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations as applicable.&nbsp;
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Engineer I

<h3>Job Description</h3>
Job Description(U)Systems Engineer with experience interfacing wideband digitizing receivers and software defined radio systems to processing software running on standard general-purpose hardware. Familiarity with the following are highly desirable: VITA-49, low-level drivers software, RHEL, multi-Gigabit Ethernet over copper and fiber optics, RF sources, amplifiers, filters, dividers, etc. (U)Successful candidate will evaluate new hardware from multiple vendors and work with the software team to integrate new hardware, optimize performance with current hardware, and troubleshoot problems with receiver/digitizer hardware. (U)&nbsp;This position will be responsible for performing site measurements, inspections, and survey at an OCONUS field site. (U)&nbsp;There will be a focus on 5G in the survey. The individual is expected to be TDY for approximately 90 days during the survey period.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

SDR, RF Systems Engineer, BS+6 or HS+10

<h3>Job Description</h3>
Job Description General AssemblerManufacturer$19.50 per hour Monday-Friday, 3:00pm-11:30pm + OvertimeDelaware, OH Temp to HireWhy You’ll Love This Job:
<ul>
<li>After being hired on, the following benefits are offered:
<ul>
<li>Health, vision, and dental insurance</li>
<li>401(k) with company match</li>
<li>Paid time off and holiday pay</li>
</ul>
</li>
<li>Opportunity to work on exciting projects </li>
<li>Overtime opportunities for extra income</li>
</ul>
What You’ll Do:
<ul>
<li>Read drawings and schematics to assemble parts</li>
<li>Use common hand tools and power tools (screwdrivers, drills, rivet guns, clamps, etc)</li>
<li>Assemble blowers, fans, and motors</li>
<li>Install panels and other components</li>
<li>Perform hands-on, physical assembly work </li>
</ul>
What We’re Looking For: 
<ul>
<li>High School Diploma or GED required</li>
<li>Experience with hand tools and assembly preferred</li>
<li>Ability to push up to 50lbs and stand for the entire shift</li>
<li>Comfortable kneeling, crawling, and stooping as needed</li>
<li>Must be able to read, write, and speak English</li>
</ul>
Apply Today!Upload your resume – no cover letter required. Our recruiters will review applications quickly and help connect you to this role and other opportunities. About DawsonDawson is a trusted staffing partner in Central Ohio. We help job seekers grow their careers with fast feedback, personalized support, and access to multiple employers through one application. #ZR

General Assembler

<h3>Job Description</h3>
Job Description
Galore Creative is a leader in the creative and tech staffing industry, dedicated to fostering innovation by connecting talented professionals with leading companies. We are committed to the success of our clients and the career growth of our candidates.
We are seeking an experienced AI Engineer to join our multidisciplinary team and play a key role in shaping our AI strategy and demonstrating the potential of AI through early-stage solutions. This position involves using deep learning, neuro-linguistic programming (NLP), computer vision, chat bots, and robotics to assist internal teams in driving diverse business outcomes and fostering innovation.
 Responsibilities:
- Understand the company's goals and challenges to plan effective AI strategies.
- Conduct research and development to advance AI strategy.
- Collaborate with cross-functional teams to identify areas where AI can stimulate business growth.
- Develop and implement efficient prototypes.
- Perform recurring tasks, such as AI strategy assessments and automating market processes.
- Perform tests and troubleshoot issues prior to final delivery of projects.
- Stay informed on the latest AI developments relevant to our business domain.
Qualifications:
- Bachelor’s/Master’s degree in Computer Science, Computer Engineering, or a related field.
- At least 3-5+ years of experience in formulating and strategizing AI solutions.
- Proven experience in applying AI to practical and comprehensive technology solutions.
- Hands-on knowledge in machine learning, deep learning, Tensorflow, Python, and NLP.
- Expertise in REST API development, NoSQL design, and RDBMS design.
- Understanding of functional design principles, object-oriented programming, and basic algorithms.
- Familiarity with cloud environments and innovation accelerators.
- An analytical, and creative mindset.
- Unwavering interest in mathematics and statistics.
- Excellent communication and interpersonal skills.
- Professional certifications in relevant areas (if required).
What We Offer:
- Competitive salary and a comprehensive benefits package.
- Opportunities to work on cutting-edge projects in state-of-the-art technology.
- Career growth opportunities in a supportive and innovative environment.
- Flexible working hours and remote work options.
 Employer Details
Galore Creative Staffing offers competitive compensation based on factors such as education, qualifications, experience, and performance. The provided pay range represents the lowest to highest compensation reasonably expected at the time of posting, which may be subject to future modifications.
We are drug free and an equal opportunity employer and are dedicated to a policy of non-discrimination in employment with regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, veteran status, or any other classification protected by federal, state, and local laws and ordinances.
This is a fantastic opportunity to work with a dynamic team that embraces a growth mindset, inspires excellence, and encourages teams and leaders to bring their best each day.
If you are looking for a diverse workplace culture and rewarding opportunity to showcase your creative genius, then apply now!

AI Engineer

<h3>Job Description</h3>
Job DescriptionAxios Professional Recruitment is currently seeking an experienced Quality Engineer located in Grand Rapids, MI. The Quality Engineer manages the 8D and NCR processes, ensuring that quality issues are thoroughly investigated and resolved. They issue RMAs to customers and handle the disposition of nonconforming materials, oversee sorting activities and issue credits to customers as needed. Additionally, they maintain communication with suppliers regarding nonconforming materials, corrective actions, material dispositions, COCs/COAs, and request credit memos as required. They own the PPAP process, including submitting PPAPs to customers (IMDS). The Quality Engineer ensures that all customer requirements are met and followed throughout the entire process, and performs audits (LPA’s, Product Audits) as required. Quality Engineer Benefits/Compensation:
<ul>
<li>$75K – 85K Salary</li>
<li>401(k) with company match</li>
<li>Medical, Dental, Vision</li>
<li>Vacation and Sick Time</li>
<li>Excellent company culture</li>
</ul>
Quality Engineer Responsibilities:
<ul>
<li>Maintain required documentation that meets the client specifications for Document Control and retrievability.</li>
<li>Interface with customer personnel and facilitate the resolution of quality issues and concerns.</li>
<li>Participate in the development and maintenance of formal quality systems, e.g. ISO 9001 &amp; IATF 16949.</li>
<li>Drive continuous improvement and best practice sharing of our quality systems and processes.</li>
<li>Facilitate problem-solving of complex issues using advanced quality tools. · Help onboard and training new team members.</li>
<li>Provide direction and coaching to less senior team members.</li>
<li>Additional functions not specifically outlined in this position description as directed by the leader.</li>
</ul>
Quality Manager Qualifications:
<ul>
<li>Bachelor of Science in Engineering or related field required. Equivalent work experience may be substituted for a degree.</li>
<li>A minimum of 5 years of Quality Engineer experience, preferably in an automotive manufacturing environment.</li>
<li>Advanced knowledge of GD&amp;T and tolerance stack up applications. · Advanced knowledge with customer specific Program Development, e.g., AIAG Automotive Core Tools.</li>
<li>Working knowledge of Quality Management Systems, e.g. ISO9001, TS16949 and ITF16949.</li>
<li>Experience with Product Warranty documentation.</li>
<li>Proven experience mentoring other Quality Engineering team members.</li>
<li>Advanced project management skills using Microsoft applications.</li>
<li>Strong verbal and written communication skills.</li>
<li>Demonstrated competency in the use of problem-solving tools, e.g., 5 why, 8D, Ishakawa Diagram, Root Cause Analysis, etc.</li>
<li>Willingness to travel domestically and internationally as required.</li>
</ul>
AXIOS Professional Recruitment. is an Employee Stock Option Plan (ESOP), a privately held organization headquartered in Grand Rapids, Michigan. As an independent, 100% employee-owned company, our team takes a personal interest in your success, listens to your needs, and forms a comprehensive plan to attract, retain, and develop your people.

Quality Engineer

<h3>Job Description</h3>
Job Description
Education/Special Training Required 
Bachelor of Science, Engineering or related subject with 2 or more years of experience in a quality or engineering discipline in a manufacturing environment, or
Master of Science, Engineering or related subject with 0 or more years of experience in a quality discipline
 
Qualifications/Work Experience Required Who We Want 
A Quality Engineer with the ability to drive quality and deliver results. Someone who is an advocate for quality and lean methodologies; a self-directed professional who can identify issues and communicate effectively to all levels within the organization; a medical device industry professional who is passionate about providing superior quality products to patients and customers.
Previous experience in a regulated environment desirable (e.g. Medical Device, Aviation, Aerospace, Automative, Defense).
CQE or equivalent course work / experience desirable
Proficient in understanding of Med Device manufacturing processes desirable.
Familiarity with ISO 13485, GDP, GMP desirable.
Lean Six Sigma training a distinct advantage.
Excellent collaboration and communication skills and attention to detail. Able to effectively communicate up/down and across different levels of the organization.
Have a good understanding of engineering and quality practices &amp; methods.
High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
Self-starter with demonstrated efficient work methods, analytical &amp; problem-solving skills and ability to handle multiple tasks in a fast paced environment.
Must be willing to work as part of a multi-site team, with some travel required.
Working knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&amp;Rs.
Highly developed problem solving and strong analytical skills.
Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach.
Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
Manages change well and adopts a continuous improvement orientation to the role
Excellent English (both oral and written)
Ability to be the voice of Quality when dealing cross functionally
 
Additional Job Details: Essential Duties &amp; Responsibilities: Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:
Work closely with operations and the business functions to ensure quality performance of product and processes.
Oversight and approval of NC &amp; CAPA, activist and mentor in problem solving and root causing activities.
Lead and participate in the development and improvement of the manufacturing processes for existing and new products.
Resolve quality issues with suppliers and partner with internal customers.
Review and approval of change management activities.
Maintain KPI for monitoring of process and supplier quality, perform analysis and interpret trends, take action as necessary.
Ownership and reporting on all quality issues associated with assigned suppliers. Ensure all assigned supplier related material quality issues are effectively communicated to key stakeholders.
Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions.
Support execution and analysis of QATs.
Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
Proficient in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.
Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections.
Proficiency in statistical methods and application. Proficiency in technical understanding of manufacturing prints and tolerancing.
Support global supplier audit team with key supplier site metrics. Negotiate sustaining quality agreements with suppliers.
Participate and interface in internal &amp; external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
Assist in the development, responsible for review &amp; approval of process and equipment validation/qualification.
Support manufacturing transfers to other plants/facilities, leading quality activities.
Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
Coach others in quality topics and activities. Main Areas of Focus:
Experience in validations (IQ, OQ, PQ)
Familiarity with Incoming inspection and part certification For your role, is this hybrid, remote or onsite
Onsite Is a degree required
Yes, Bachelors in an engineering or science discipline. Top 3 skills 1. Adaptability 2. Attention to Detail 3. Problem solving Interview (1, 2 rounds Onsite or virtual)
1 or 2. (Still confirming with my manager) Temp to perm or just contract
Just a contractor. But if a position does open up we are ok with them applying for the full time position. Can you give us an overview of the project this resource would be working on and what the day-to-day activities would look like
Working on: o This project will be supporting daily production line support when needed. Such as quality decision making on rejected material or not following the process. o Performing software and equipment validations for incoming inspection.
Completing part certifications on supplied raw materials.
Day-to-day o Checking on production o Progress/close NCs o Progressing validations o Progressing part certs. o The majority of the time will be spent at a computer

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