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<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

Senior Engineer, Quality Assurance Engineering

<h3>Job Description</h3>
Job DescriptionAbout The Opportunity: Guardian is seeking a Kitchen Fire Suppression Technician This position requires the ability to service, inspect and repair kitchen suppression systems for established commercial customers on a scheduled basis and must be available for on call rotation. Job Duties: Inspecting and repairing pre-engineered restaurant fire suppression systems manufactured by ANSUL, Pyro Chem, Range Guard and Piranha. Thorough understanding of NFPA, manufacturer and local fire codes for restaurant fire suppression systems. Performing on-site emergency troubleshooting of fire suppression systems. Identifying NFPA code and non-conformance issues. Maintain proper documentation for all work performed. Perform fire marshal tests and inspections. Available for on-call rotation. Qualifications: A current and valid driver's license with 3 or less points is required. Three years of licensed driving experience is required. Two or more years' experience inspecting restaurant fire suppression systems. Must have knowledge and understanding of all NFPA codes. Willing to work varied hours, nights, early morning and weekend shift when needed. Must have excellent attendance and can handle responsibility. Must be comfortable working on ladders 6 to 12ft and on lifts. Ability to lift up to 70lbs, to work overhead and in unusual or small spaces such as attics and crawl spaces. Skills to communicate well with customers and explain the work being done and any repairs that are necessary. Skills to write well and be very detailed in your write up on service work. Must be well organized and be able to keep track of service tickets and process all required documents for each service performed. Benefits 401K with a company match Medical, Dental and Vision Insurance Company paid Short Term Disability Company paid Long Term Disability Company paid Life and AD&amp;D insurance Pre-tax accounts for health and dependent care Aflac Vacation and Personal time Paid holidays Tuition Reimbursement Company vehicle Guardian Fire Protection Services is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on his or her age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, or because he or she is an individual with a disability, protected veteran or other status protected by federal, state, and local laws. This link leads to the machine-readable files that are made available in response to the federal Transparency in Coverage Rule and includes negotiated service rates and out-of-network allowed amounts between health plans and healthcare providers. The machine-readable files are formatted to allow researchers, regulators, and application developers to more easily access and analyze data. #GuardianFireProtection #Rockville #Maryland #Experienced #KitchenFireSuppression #Technician #FireSuppression #KitchenSuppression #FireProtection Benefits found in job post 401(k) Vision insurance

Kitchen Fire Suppression Technician

<h3>Job Description</h3>
Job DescriptionLocation: Tamarac, FL (Onsite)Schedule: Monday – Friday, 8:00 AM – 5:00 PM EST (occasional additional hours as needed)Travel: Up to 50% (Primarily domestic)Salary: $85,500.00Employment Type: Direct Hire OverviewWe are seeking a highly motivated Quality Engineer to join a leading manufacturing organization. In this role, you will play a pivotal role in ensuring the consistent quality of materials received from suppliers by auditing, developing, and maintaining strong relationships with key partners. You will also support internal quality efforts and help maintain the organization’s Quality Management System (QMS). Key Responsibilities
<ul>
<li>Collaborate with engineering and purchasing teams to support supplier development and onboarding.</li>
<li>Lead the PPAP (Production Part Approval Process) for new and existing products.</li>
<li>Audit and evaluate supplier facilities and processes, ensuring compliance and driving continuous improvement.</li>
<li>Manage Supplier Corrective Actions (SCAR) and validate implementation during audits.</li>
<li>Analyze process capability (Cp/Cpk) and provide training/support in LEAN and Six Sigma tools.</li>
<li>Maintain QMS documentation, audit schedules, supplier reports, and performance metrics.</li>
<li>Work closely with quality inspectors and engineering teams to ensure alignment on internal and external quality initiatives.</li>
</ul>
Must-Have Qualifications
<ul>
<li>Bachelor’s degree in Mechanical, Industrial, or related Engineering field.</li>
<li>Several years of engineering experience in a manufacturing environment.</li>
<li>Previous experience as a Quality Engineer.</li>
<li>Willingness to travel up to 50% for supplier visits and audits.</li>
<li>Hands-on experience with supplier auditing and corrective action processes.</li>
<li>Familiarity with quality core tools: process flow, PFMEA, control plan, etc.</li>
</ul>
Preferred Qualifications
<ul>
<li>Six Sigma Green Belt or Black Belt Certification</li>
<li>Kaizen event leadership experience</li>
<li>Lean Certification</li>
<li>Trained Auditor credentials</li>
<li>Experience with SAP and lean material management systems</li>
</ul>
Interview Process
<ul>
<li>Initial virtual interview with the hiring team</li>
<li>PI Assessment and follow-up virtual interview with hiring and HR representatives</li>
</ul>
Benefits Include
<ul>
<li>100% employer-paid medical coverage</li>
<li>Additional benefits including:
<ul>
<li>Dental</li>
<li>Vision</li>
<li>Life Insurance</li>
<li>401(k) match</li>
<li>Short-term and long-term disability plans</li>
</ul>
</li>
</ul>

Quality Engineer

<h3>Job Description</h3>
Job Description
Eagle Systems is a "Made In America" machine manufacturer building EMBELLISHMENT machinery for the printing industry. We are a family owned company with a worldwide outstanding reputation for quality built Hot and Cold Foil machines. We design, manufacture, install and service our equipment. Our business is growing and the organisation is being resized to accommodate the same.
We are looking for a FULL TIME Machine Division Manager
This person will report to the Production Manager who is responsible for four processing departments; machining, welding, finishing and assembly. .Approximately 80% of the 3,500+ parts for the major assemblies manufactured by Eagle are made in-house. Given the continued growth of the company's products and clients, we are seeking a skilled Machining Division Manager to be added to the team.
Specifically, the ideal candidate will have ; Five plus years of experience with...
<ul>
<li>CNC programming a must! </li>
<li>Ability to run the following machines.....</li>
<li>Vertical Mills, Hass Lathes, Hass VM, Hurco VM, Protrax VM</li>
<li>Drill presses.</li>
<li>Lathes.</li>
<li>Must have your own Precision measuring machinist tools i.e. Calipers, Dial Indicators, Micrometers, etc.</li>
<li>Design oriented given the required interface with product engineers</li>
<li>Skilled at reading and understanding detailed schematics.</li>
<li>Detail oriented given that precision parts are being produced.</li>
<li>Ability to multi-task</li>
<li>Good interpersonal skills</li>
</ul>
** In addition to the above and in order to be successful, candidate needs to be a team player with a can do attitude in order to integrate with the existing team.
****If this sounds like the type of company you would like working for, please check out our website at <a href="http://www.thefoilexperts.com" target="_blank">www.thefoilexperts.com</a>.
Company DescriptionEagle Systems is a privately owned manufacturing company established in 1990. It’s recognized as the worldwide industry leader in designing, manufacturing, installing, and servicing cold foil processing systems. In addition, it designs and manufactures other specialized equipment for the printing and packaging industry. More than 1,000 cold and hot foil processing systems are now being supported around the globe. Its customer base is loyal, business is growing, and the organization is being resized to accommodate the same: organization structure, staffing, and management expertise 
<h3>Company Description</h3>
Eagle Systems is a privately owned manufacturing company established in 1990. It’s recognized as the worldwide industry leader in designing, manufacturing, installing, and servicing cold foil processing systems. In addition, it designs and manufactures other specialized equipment for the printing and packaging industry. More than 1,000 cold and hot foil processing systems are now being supported around the globe. Its customer base is loyal, business is growing, and the organization is being resized to accommodate the same: organization structure, staffing, and management expertise

Machine Division Manager

<h3>Job Description</h3>
Job Description
AST SpaceMobile is building the first and only global cellular broadband network in space to operate directly with standard, unmodified mobile devices based on our extensive IP and patent portfolio and designed for both commercial and government applications. Our engineers and space scientists are on a mission to eliminate the connectivity gaps faced by today's five billion mobile subscribers and finally bring broadband to the billions who remain unconnected.
Summary:
The Principal Engineer of RF systems should be an expert on RF communications system with strong knowledge/experience of key RF subsystems/components, particularly the RF transceivers and filters. The successful candidate should be innovative and creative, as well as willing to challenge the status quo. He or she should work well in teams while also having the ability to lead a small team and/or to work assignments autonomously.
Key Responsibilities:
<ul>
<li>Design, analysis and implementation of the satellite RF systems, including the Q/V band gateway link system and lower frequency user link system to meet the mission requirements</li>
<li>Conduct comprehensive link budget calculations and interference analysis</li>
<li>Manage major suppliers for the RF systems.</li>
<li>Develop RF system test plan and work with the test team for test result review and non-conformance investigation, root cause analysis and resolution</li>
</ul>
Required Experience &amp; Skills
<ul>
<li>Minimum 5 years of hands-on experience in RF systems with college degree or 9 years' experience with an advanced degree in RF communications/electrical engineering fields or other related fields.</li>
<li>In-depth understanding of antenna theory and parameters, including radiation patterns, gain, efficiency, and polarization.</li>
<li>Experience in SDR and DSP (Digital Signal Processing), as well as Python/Matlab for automation and signal analysis</li>
<li>Excellent English written and verbal communication skills</li>
</ul>
Preferred Qualifications
<ul>
<li>Experience with satellite payload design/analysis and/or wireless communications will be a plus.</li>
<li>Experience with antenna design and high-frequency electromagnetic simulation using tools like Ansys HFSS is a plus.</li>
<li>Supplier management experience preferred.</li>
</ul>
Soft Skills
<ul>
<li>Demonstrated ability to work in a multidisciplinary team with other engineers</li>
<li>Flexibility/adaptability in a fast-paced &amp; dynamic environment</li>
</ul>
AST SpaceMobile is an Equal Opportunity, at will Employer; employment is governed on the basis of merit, competence and qualifications and will not be influenced in any manner by race, color, religion, gender, national origin/ethnicity, veteran status, disability status, age, sexual orientation, gender identity, marital status, mental or physical disability or any other legally protected status.

Principal Engineer, RF System

<h3>Job Description</h3>
Job Description
Position Summary:
We are seeking a CAPA Engineer (Technical Writer) to support our Quality Control Department, with a focus on the Corrective and Preventive Action (CAPA) process. The selected candidate will manage all phases of the CAPA lifecycle—including initiation, investigation, implementation, and closure—in alignment with FDA, ISO, and global regulatory standards. This role requires collaboration with cross-functional teams to address deviations, non-conformances, and audit findings using a structured, traceable, and well-documented approach. Strong technical writing skills and a solid understanding of medical device regulatory requirements are essential.
Location: Eastern Region, Puerto Rico 

Key Responsibilities:

 CAPA Initiation &amp; Writing
<ul>
<li>Draft and initiate CAPAs per internal procedures and regulatory requirements</li>
<li>Define scope, issue, risk impact, and acceptance criteria</li>
</ul>

CAPA Investigation
<ul>
<li>Conduct root cause analyses using tools like 5 Whys, Fishbone, FMEA</li>
<li>Collect and document supporting evidence; conduct technical interviews</li>
</ul>

 Action Planning &amp; Implementation
<ul>
<li>Develop effective, timely action plans with responsible parties</li>
<li>Coordinate implementation across functions: engineering, validation, microbiology, etc.</li>
<li>Define and document effectiveness checks</li>
</ul>

CAPA Closure
<ul>
<li>Verify and document completion and effectiveness of actions</li>
<li>Ensure all documentation is audit-ready and compliant with QMS</li>
</ul>

Documentation &amp; Quality Systems
<ul>
<li>Use electronic CAPA platforms (Track Wise, Master Control, EtQ Reliance, etc.)</li>
<li>Ensure compliance with Good Documentation Practices (GDP)</li>
<li>Participate in CAPA boards and quality review meetings</li>
</ul>
Regulatory &amp; Technical Expertise:

<ul>
<li>Deep understanding of medical device regulations:
<ol>
<li>21 CFR Part 820, ISO 13485, ISO 14971, MDR 2017/745, ICH Q9/Q10</li>
</ol>
</li>
<li>Experience with FDA inspections and Notified Body audits</li>
<li>Strong grasp of CAPA systems and identifying systemic issues</li>
</ul>

Education &amp; Experience Requirements:
<ul>
<li>Bachelor’s degree in Electric Engineering or Mechanical Engineering is required. </li>
<li>3+ years of experience managing CAPAs in the medical device industry</li>
<li>Regulatory audit experience (FDA, ISO, EU)</li>
<li>Quality certifications (CQE, CAPA Specialist, Lean Six Sigma) – a plus</li>
</ul>

Technical &amp; Process Knowledge:
<ul>
<li>Familiarity with medical device manufacturing processes</li>
<li>Understanding of validation protocols (IQ, OQ, PQ)</li>
<li>Experience with statistical tools (e.g., Minitab, advanced Excel)</li>
</ul>

Key Skills &amp; Competencies:
<ul>
<li>Excellent technical writing in English and Spanish</li>
<li>High attention to detail with a strong compliance mindset</li>
<li>Strong communication and project coordination skills</li>
<li>Ability to manage multiple priorities under strict deadlines</li>
<li>Team-oriented with initiative and independence</li>
</ul>

Join us in contributing to the advancement of safe, effective medical devices by ensuring quality system integrity through expert CAPA process execution.

CAPA Engineer

<h3>Job Description</h3>
Job Description
1 FULL TIME POSITION (7am to 3:30 pm) available to work in our shop location in Edwardsville PA location. Must be mechanically inclined able to work with hand tools and able to lift up to 45 lbs. These positions will require you to stand at your work station, daily job duties maybe one of the following: discharging fire extinguishers, hydro-testing of cylinders, cleaning extinguisher valves, recharging extinguishers, cleaning extinguishers, loading and unloading van. This is an on the job training position. Must have you own transportation to and from work daily. We pay weekly and offer paid time off starting after 90 days, IRA. Steady Work,&nbsp; M-F 7am to 3:30 pm. if possible when applying please attach a resume.

Fire Extinguisher shop tech.

<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>Validation Specialist</li>
</ul>
Qualifications:
<ul>
<li>Bachelor's Degree in Engineering.</li>
<li>Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.</li>
<li>Experience in direct process / manufacturing areas.</li>
<li>Must be fully bilingual (English / Spanish) with excellent oral skills.</li>
<li>Must be proficient using MS Windows and Microsoft Office applications.</li>
<li>Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.</li>
<li>Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.</li>
<li>SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) &amp; Site Acceptance Test (SAT).</li>
<li>Strong knowledge in medical devices equipment preferred.</li>
<li>Technical Writing skills and investigations processes.</li>
<li>Available to work extended hours, possibility of weekends and holidays.</li>
</ul>

LL02-250624 Validation Engineer

<h3>Job Description</h3>
Job Description
Seeking an experienced Cylindrical Grinder Operator and Machinist for our Shelbyviile KY plant. M-F schedule with overtime opportunities.&nbsp; 1st shift. Pay based on experience.&nbsp; May pay relocation for right candidate.
Company DescriptionWe are a smaller machine shop that manufactures one specific product. Low pressure fun work environment. 
<h3>Company Description</h3>
We are a smaller machine shop that manufactures one specific product. Low pressure fun work environment.

Cylindrical Grinder Operator/ Machinist

<h3>Job Description</h3>
Job DescriptionThe Quality Engineer is responsible for maintaining and improving quality processes throughout production. This includes managing corrective actions, investigating complaints, conducting quality inspections, and ensuring training compliance. The role also involves working closely with process engineers to address root causes of quality issues and ensuring proper documentation is maintained for internal and external use. Pay Scale $30,000 to $80,000. Benefits Include Medical, Dental and Vision. Responsibilities:
<ul>
<li>Identify and implement internal corrective actions to address quality concerns.</li>
<li>Collaborate with process engineers to determine root causes of defects or complaints.</li>
<li>Document and maintain records of corrective actions and submit required reports to customers and internal stakeholders.</li>
<li>Perform quality checks at the end of every process to ensure compliance with company standards.</li>
<li>Utilize testing tools and equipment, including microscopes, solder testing equipment, and other specialized instruments, for product evaluation.</li>
<li>Follow established procedures (14/15 procedures) to ensure consistent quality testing.</li>
<li>Investigate product complaints to identify root causes.</li>
<li>Work closely with process engineers to develop and implement corrective measures.</li>
<li>Document and communicate investigation findings and resolutions to stakeholders.</li>
<li>Audit staff training based on training schedules and documented procedures.</li>
<li>Verify that employees have completed training and are following approved processes.</li>
<li>Address discrepancies, provide additional training as needed, and reschedule training sessions to ensure compliance.</li>
<li>Regularly inspect and calibrate testing tools to maintain their accuracy and reliability.</li>
<li>Monitor the use of tools and equipment during quality checks to ensure compliance with standards.</li>
<li>Suggest Process Improvement</li>
<li>Maintain detailed records of quality inspections, corrective actions, and training audits.</li>
<li>Prepare reports on quality performance metrics, process improvements, and training compliance.</li>
<li>Ensure all documentation complies with customer and internal requirements.</li>
</ul>
 Qualifications:
<ul>
<li>Bachelor's degree in Engineering, Quality Assurance, or a related field (or equivalent experience).</li>
<li>Previous experience in a quality engineering role, preferably in a manufacturing or production environment.</li>
<li>Familiarity with quality management systems and industry standards.</li>
<li>Strong knowledge of quality assurance standards, tools, and techniques.</li>
<li>Experience with root cause analysis and corrective action implementation.</li>
<li>Proficiency in using inspection equipment such as microscopes and solder testing tools.</li>
<li>Strong attention to detail and problem-solving abilities.</li>
<li>Effective communication and collaboration skills.</li>
<li>Organizational and documentation skills.</li>
</ul>
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