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<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 Scientist for Biotech Manufacturing Equipment</li>
</ul>
Qualifications:
<ul>
<li>Bachelor's Degree in Science or Engineering.</li>
<li>Minimum of 3 years of experience in direct pharmaceutical, medical device or preferably (biotechnology) industries.</li>
<li>Must be fully bilingual (English / Spanish) with excellent oral skills.</li>
<li>Experience in developing Systems Development Life Cycle (SDLC) documents such as VP, URS, DS, RA, IQ, OQ, PQ, TMX and so forth. Includes execution of protocols IOPQ, managing deviations, and reports generation.</li>
<li>Preferably experience in the Biotech industry.</li>
<li>Technical writing skills and investigations processes.</li>
<li>Available to work extended hours, possibility of weekends and holidays.</li>
</ul>

MF01-062725 CQV Scientist for Biotech Manufacturing Equipment

<h3>Job Description</h3>
Job Description
PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning and Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.
Job required Qualification:
<ul>
<li>Bachelor of Science degree, Engineering, or Equivalent training and experience.</li>
<li>More than 5 years of experience in a regulated environment.</li>
<li>3 years of experience authorizing procedural and commercial marketing documents.</li>
<li>More than 3 years of experience with clean rooms, aseptic suites, single-use technology, bioreactors, and cell culture.</li>
<li>Experience in mechanic and Industrial engineering </li>
<li>Strong working knowledge of pharmaceutical industry regulations (GMP, GDP, ICH, etc.)</li>
<li>Strong understanding and working knowledge of project lifecycle, entrepreneurial mindset, and excellent written and verbal communication skills.</li>
<li>Strong relationship management, leadership, and organizational skills.</li>
<li>Strong working knowledge in Microsoft suites, and Smartsheet.</li>
</ul>
Job responsibilities and Duties:
<ul>
<li>Develop and execute equipment qualification protocols for all manufacturing, processing, and packaging equipment and facilities/utilities supporting these operations.</li>
<li>Develop and execute process validation protocols for all manufacturing and packaging processes of commercial products (and R&amp;D products as applicable).</li>
<li>Develop and execute validation/verification protocols for all commercial and R&amp;D manufacturing, processing, and packaging equipment.</li>
<li>Analyze data, utilizing statistical methods, generated by validation studies performed by the Validation group to determine process capabilities.</li>
<li>Gather photocopies and compile relevant documentation such as executed batch records, certificates of analysis, equipment logs, equipment qualifications, raw material certificates of analysis.</li>
<li>Investigate and resolve deviations/exceptions from the predefined acceptance criteria.</li>
<li>Draw conclusions from data, observations, deviation/exception, and investigation as to whether the process is considered valid.</li>
<li>Write summary reports (closeout report when applicable) for validation/qualification protocols following criteria as outlined within the validation/qualification procedures and policies.</li>
<li>Maintain protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner.</li>
<li>Ensure protocols, verifications, validation plans, and summary reports generated during validation/ qualification activities are stored according to the procedure.</li>
<li>Maintain current knowledge in the areas of compliance and validation and other regulatory issues that may impact the Company. Work proactively to maintain the highest level of compliance in all areas. Gather current knowledge from QA/QC, regulatory, periodicals, and/or appropriate training programs.</li>
<li>Interact and coordinate compliance efforts with other departments including, but not limited to, Operations, Engineering, QA, laboratories (QC and R&amp;D), and R&amp;D to provide a high degree of assurance that all qualification/validation activities, where appropriate, are completed.</li>
<li>Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.</li>
<li>Perform other related duties as assigned to meet departmental and Company objectives.</li>
</ul>

Validation Engineer

<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>Cleaning Validation Scientist </li>
</ul>
Qualifications:
<ul>
<li>Bachelor's Degree in Science or Engineering.</li>
<li>Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.</li>
<li>Solid experience generating Cleaning Validation Protocols for Manufacturing Equipment, according to the strategy depicted in the Cleaning Validation Master Plan</li>
<li>Advanced validation knowledge (cleaning validation, equipment qualification, sterilization).</li>
<li> Applies extensive technical validation expertise and has full knowledge of other related disciplines.</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>Technical Writing skills and investigations processes.</li>
<li>Available to work extended hours, possibility of weekends and holidays.</li>
</ul>

MF01-070125 Cleaning Validation Scientist

<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>Sr. Quality Engineer</li>
</ul>
Qualifications:
<ul>
<li>Must have fundamental knowledge/experience in statistics, SPC, validation activities, Installation Qualification, Operation Qualification, Performance Qualification and Product Performance Qualification.</li>
<li>Knowledge in DOE, Six Sigma, and product transfer.</li>
<li>Must be knowledgeable of GMP and ISO evidenced by successful completion of training in GMP and, auditing principals.</li>
<li>Prior experience auditing FDA regulations.</li>
<li>Bilingual (English and Spanish), possess good communication and analytical skills, and availability to work under deadlines.</li>
<li>Credentials of a Certified Quality Engineer are a plus.</li>
<li>Able to apply comprehensive knowledge of a particular field of specialization to the completion of assigned task.</li>
<li>This is an onsite role.</li>
<li>Bachelor’s degree in Engineering (Industrial, or CQE preferred), advanced degree or process towards advanced degree is a plus.</li>
<li>A minimum of (7) seven years’ experience in manufacturing, quality control, quality assurance, or regulatory compliance, preferably in the medical device or pharmaceutical industry.</li>
</ul>
Responsibilities:
<ul>
<li>Review plant defect reports, customer complaints, failure investigations and audit findings to assess manufacturing related issues that may impact quality and recommend courses of corrective action.</li>
<li>Conduct manufacturing non conformances investigations, customer complaints, CAPA, failure investigations and audit findings.</li>
<li>Escalate manufacturing related issues that may impact quality and recommend courses of corrective action.</li>
<li>Participate in regulatory agencies audits.</li>
<li>Assist in the investigation of product non conformances and the gathering of information during regulatory inspections and field actions when required.</li>
<li>Approve or review product investigations reports.</li>
<li>Perform and report line defects trend analysis, cost of quality, and period quality summaries.</li>
<li>Participate in new product or technology transfers to assess the impact they may have on the quality and reliability of the product – assist in process validation protocol.</li>
<li>Follow-upon commitments to FDA and ISO observations for manufacturing related issues and report trends.</li>
<li>Perform quality system audits to determine compliance to FDA, ISO, and internal quality systems regulations and perform quality system surveys to evaluate the overall quality capability of a prospective or actual supplier or contractor.</li>
<li>Participate in the development, delivery, and administration of quality training programs including but not limited to GMP.</li>
<li>Be an active member in facility continuous improvement initiatives to assure continuation of quality measurement, planning, and improvement.</li>
<li>Provide leadership and guidance to a team of hourly or salary associates, including assigning tasks, setting clear goals, and monitoring performance, as required.</li>
<li>Facilitate training sessions to ensure team members are equipped with necessary skills and knowledge.</li>
<li>Develop individual team members through coaching and mentoring.</li>
</ul>

LL01-060325 Sr Quality Engineer

<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
iRF Intelligent RF Solutions is a leader in providing tailored solutions for SIGINT and EW missions. We understand our customers’ challenges and use our expertise to create solutions. We are not just a supplier, but a problem-solving partner with a strong foundation in supporting global defense and intelligence missions. 
We are dedicated to attracting high-achieving individuals. Our team members are bound by a common purpose - a commitment to our customers’ missions. 
Our culture is anchored in our steadfast values, our collaborative spirit, and a relentless pursuit of excellence where we consistently endeavor to find a way or make one.
 
PRINCIPAL RF DESIGN ENGINEER – Microwave Receivers
The following statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all essential functions, duties and skills required of personnel so classified. Management retains the discretion to add or change the duties at any time.
 
Job Description:
Provides technical expertise in the design and development of state-of-the-art, RF/microwave receivers, frequency-converters and related products for SIGINT, EW and radar applications. This position requires experience in design of RF/MW circuitry through at least 18GHz using SMT components on PCB substrates. 
The successful candidate must have experience performing top-level requirements analysis and design of system architecture, allocating functional requirements for sub-assemblies.
Essential Functions:
<ul>
<li>Serve as an individual RF/MW design contributor and lead engineer for key design projects.</li>
<li>Provide technical leadership and mentoring to more junior team members.</li>
<li>Make technical presentations to customers to support design review requirements.</li>
<li>Provide technical support for Business Development activities including white papers and technical proposals.</li>
<li>Performs other duties as assigned.</li>
</ul>
Qualifications:
<ul>
<li>At a minimum must have a BSEE and 10+ years of related experience in RF/microwave circuit design.</li>
<li>Hands-on design experience in PCB-based design of RF/MW circuitry supporting receivers and frequency converters to 18GHz and beyond is required. </li>
<li>Wide bandwidth, high dynamic range, super-het receiver design experience is desired. Additionally, experience in mmW frequency range design, wideband digitization, and low SWaP design is helpful.</li>
<li>Well-versed in receiver/frequency converter system design, including frequency planning and spur analysis, RF/MW filter technologies, cascade GNIP analysis, MW mixers, frequency generation using PLL ICs, and design trade-offs.</li>
<li>An individual with a high degree of technical competence and good interpersonal skills will provide individual technical contributions as well as technical leadership and guidance to other project team engineers.</li>
<li>Must possess leadership qualities and be able to work well with and lead a diverse group of engineering disciplines.</li>
<li>Familiar with computer design tools including Keysight Genesys, OrCad, MATLAB, PSPICE, or other tools.</li>
<li>Must have the ability to obtain security clearance.</li>
<li>Must be able to pass a preemployment drug screening and background check.</li>
</ul>
Salary Range: $105,000.00 - $240,000.00 per year.
Location: Onsite in Sparks, MD with a 9/80 schedule. Every other Friday OFF. 
Please be aware many of our positions require the ability to obtain security clearance. Security clearances may only be granted to U.S. citizens. In addition, applicants who accept a conditional offer of employment may be subject to government security investigation(s) and must meet eligibility requirements for access to classified information. 
IRF Solutions is proud to be an Affirmative Action/Equal Opportunity/ Disability/ Veterans Employer. IRF Solutions is committed to treating all employees and applicants for employment with respect and dignity and maintaining a workplace that is free from unlawful discrimination. IRF Solutions maintains a drug-free workplace and performs pre-employment substance abuse testing and background checks, where permitted by law. Proof of employment authorization will be required. IRF Solutions is not required to sponsor applicants for work visas. As this position will require access to export-controlled information, only applications from “U.S. persons” within the meaning of the International Traffic in Arms Regulations and Export Administration Regulations will be considered. IRF Solutions is not required to seek export license for applicants who do not meet this requirement. As an equal opportunity employer, IRF Solutions, is committed to a diverse workforce. EOE, including disability/vets. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access the IRF Solutions career website, because of your disability. You may request reasonable accommodation by email at <a href="mailto:hr@irf-solutions.com" target="_blank">hr@irf-solutions.com</a> or by phone at (443) 595-8500. 
 
EOE, including disability/vets.

RF Engineer IV

<h3>Job Description</h3>
Job Description
About the Company
O'Fallon Casting is a global leader in the production of high-quality aluminum alloy investment castings. Since 1969, our family-owned company has been dedicated to delivering precision-engineered solutions for the aerospace, defense, and commercial markets. Operating from our modern 75,000-square-foot foundry in O'Fallon, Missouri, we specialize in complex, castings that meet the rigorous demands of the world's leading aerospace and defense contractors. Our constructive culture fosters innovation, collaboration, and excellence, ensuring that we remain at the forefront of the industry. Please consider joining our growing team
PRIME RESPONSIBILITIES AND MAJOR FACTORS IN EVALUATING PERFORMANCE:
 
The Quality Engineer will provide quality assurance support to the product development team, resolving bugs, defects, and other potential issues and ensuring that products meet customer specifications.
 
Duties/Responsibilities:
<ol>
<li>Reviews design plans, process procedures, test procedures, and quality manuals to understand the scope, requirements, and function of products.</li>
<li>Ensures products meet the organizations and customers' quality and product integrity requirements.</li>
<li>Supports product development or operations team by providing analysis and expertise throughout the inspection process.</li>
<li>Identifies root causes of problems in the production process; recommends and/or implements corrective measures.</li>
<li>Analyzes data to identify trends in product quality or defects with the goal of mitigating and preventing recurrence and future defects.</li>
<li>Supervisor and/or experienced Quality Engineer screens assignments for unusual or difficult problems and selects techniques and procedures to be applied on non-routine work. Receives close supervision on new aspects of assignments. Significant departures from guidelines must be cleared with the Quality Manager.</li>
<li>Maintain accurate quality records and documents as required by customers and/or other sources.</li>
<li>Maintain a smooth production flow through the quality inspection departments to ensure meeting customer and Company schedules.</li>
<li>Observe O'Fallon Casting code of conduct, safety and quality principles.</li>
<li>Perform other duties as required.</li>
</ol>
 
Required Skills/Abilities:
Excellent verbal and written communication skills.
Excellent organizational skills and attention to detail.
Extensive knowledge of or the ability to quickly learn the organizations production processes.
Excellent interpersonal skills with ability to serve as a liaison with developers, project managers, and customer support.
Strong analytical and problem-solving skills. 
Proficient with Microsoft Office Suite or related software.
Education and Experience:
Bachelor's degree in Engineering or related discipline required.
7-10 years of Aerospace Experience Preferred.
AS9100 experience preferred.
Nadcap experience preferred.
PPAP experience preferred.
GD&amp;T experience preferred.
Full knowledge of performing Final Inspection. (Requires Passing Test)
Perform tensile testing. (Requires Passing Test)
Conduct hardness testing. (Requires Passing Test)
Perform chemical analysis. (Requires Passing Test)
Complete RCCA (Acceptance of 5 Why or 8D)
FPI (Pass Level 1 Test)
Heat Treatment (Pass Test)
Welding (Complete Nadcap Checklist)
Radiography (Pass Level 1 Test)
Complete Full FAI AS9102 Forms 1, 2, and 3 (Acceptance in Net Inspect)
Knowledge of Laser Scanning Principles (Perform Laser Scanning Demo for IC201 Class)
Develop a complete APQP package (Acceptance in Net Inspect)
DQR (Designated Quality Representative Certification) for the following:
Parker 
Collins
Pratt
General Dynamics
General Electric (MRAS)

Quality Engineer

<h3>Job Description</h3>
Job Description
Position Purpose:
We are seeking an experienced RF Engineer to join our team and lead advanced radio frequency testing, measurement, and analysis initiatives. This role requires deep technical expertise in RF measurement systems and laboratory instrumentation, with a focus on materials characterization and imaging system development. The successful candidate will be responsible for maintaining critical RF measurement infrastructure while advancing our capabilities in millimeter wave imaging and spectral analysis.
Essential Duties and Responsibilities:
RF Measurement &amp; Instrumentation
<ul>
<li>
Operate, calibrate, and maintain network analyzers and associated RF measurement equipment to ensure optimal performance and accuracy
</li>
<li>
Design, configure, and execute laboratory RF measurements of materials, including dielectric characterization and electromagnetic property analysi
</li>
<li>
Establish and maintain calibration procedures for all RF measurement systems and components
</li>
<li>
Troubleshoot complex RF measurement setups and resolve technical issues to minimize downtime 
</li>
</ul>
System Integration &amp; Maintenance
<ul>
<li>
Ensure operational readiness of all RF measurement systems including cables, horn antennas, waveguides, and supporting infrastructure
</li>
<li>
 Develop and implement preventive maintenance schedules for critical RF equipment
</li>
<li>
Verify specifications and performance parameters for RF components throughout the procurement lifecycle
</li>
<li>
Maintain detailed documentation of system configurations, calibration records, and maintenance activities
</li>
</ul>
Advanced Imaging &amp; Analysis
<ul>
<li>
Collect, process, and analyze data from laboratory scanning arrays and commercial millimeter wave (MMW) imaging system
</li>
<li>
Perform image reconstruction and signal processing to extract meaningful information from RF/MMW datasets
</li>
</ul>
Required Knowledge, Skills &amp; Abilities:
<ul>
<li>Expert-level knowledge of RF calibration techniques and measurement uncertainty analysis</li>
<li>Proven experience in laboratory RF characterization of materials and components</li>
<li>Strong background in antenna systems, waveguide technology, and RF component integration</li>
<li>Experience with millimeter wave imaging systems and signal processing techniques</li>
</ul>
Education/Experience:
A master’s degree in engineering from an accredited college or university with at least 12 years of experience OR a Ph.D. in engineering from an accredited college or university with at least 6 years of post graduate experience that demonstrates a professional knowledge of systems development and technology development.
Certificates &amp; Licenses:
None Required
Clearance:
The ability to obtain a Department of Defense Secret clearance and Department of Homeland Security Fitness is required for this position.
Supervisory Responsibilities:
Supervision of the technical activities performed by the more junior staff members assigned to the project is required for this position.
Working Conditions/Equipment:
The incumbent professional is expected to be present at the work site and/or be available during regular business hours. He/she should also generally be available via e-mail or phone during non-business hours as needed to address critical issues or emergencies.
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.
 Powered by ExactHire:178682

RF Engineer- Contingent

<h3>Job Description</h3>
Job Description
About the Company
O'Fallon Casting is a global leader in the production of high-quality aluminum alloy investment castings. Since 1969, our family-owned company has been dedicated to delivering precision-engineered solutions for the aerospace, defense, and commercial markets. Operating from our modern 75,000-square-foot foundry in O'Fallon, Missouri, we specialize in complex, castings that meet the rigorous demands of the world's leading aerospace and defense contractors. Our constructive culture fosters innovation, collaboration, and excellence, ensuring that we remain at the forefront of the industry. Please consider joining our growing team
Supplier Quality Specialist
Responsibilities
<ul>
<li>The position is responsible for participating in the development and maintenance of Supplier Quality Assurance initiatives and processes and for supporting Strategic Sourcing in the overall supplier management</li>
<li>Execute the delegation program with suppliers to allow self-inspections and continually supply products at a high level of performance for Quality and Delivery</li>
<li>Execute supplier development activities with new suppliers</li>
<li>Participate in supplier process review including risk assessment</li>
<li>Drive supplier Improvement plans for low performing suppliers and run periodic focus reviews between suppliers and company management</li>
<li>Ensure supplier compliance to PO flow down and supplier Quality Manual requirements</li>
<li>Conduct supplier on-site and virtual audits per AS9100/ ISO 9001 requirements</li>
<li>Co-lead containment activities between Supplier and company on supplier escapes</li>
<li>Lead effective Root Cause Corrective Action for assigned Supplier Corrective actions (SCAR's) with suppliers to closure</li>
<li>Review and Approve Supplier First Article Inspection (FAI)</li>
<li>Assist suppliers with any non-conformance in FAI reporting</li>
<li>Assist in maintaining the company Approved Supplier List (APL)</li>
<li>Report monthly / Quarterly supplier performance data to supply base and company</li>
<li>Update and Maintain Supplier Quality KPI's on monthly basis</li>
<li>Coordinate with Purchasing and company when source inspection is required to either perform the inspection or arrange for subcontract source provider</li>
</ul>
 
Qualifications
<ul>
<li>Bachelor's Degree or the equivalent combination of related education, training, and experience with a minimum of 3-5 years of experience in a related position with experience in AS9100 / ISO 9001 Quality management system</li>
<li>2-3 years Auditing experience in AS9100 / ISO 9001 Quality Systems</li>
<li>Working Knowledge of Root Cause Corrective Action (RCCA) methodology which includes 8D, 5 whys and Fishbone diagrams</li>
<li>Working knowledge of quality tools such as FMEA, Control plans, SPC and Gage R&amp;R</li>
<li>Working knowledge of casting, machining, and finishing processes</li>
<li>Experience in developing and approving First Article Inspections (FAI)</li>
<li>Ability to interpret Drawings and Industry Specifications</li>
<li>Ability to understand and communicate machining process plans</li>
<li>Familiar with CAD, Solidworks preferred</li>
<li>Excellent communication skills and be able to communicate clearly and professionally, both orally and in writing</li>
<li>Ability to author reports, business correspondence, work instructions and procedure manuals</li>
</ul>

Supplier Quality Specialist

<h3>Job Description</h3>
Job Description
At Cadence, we improve product performance by building solution-oriented partnerships with our customers and delivering highly technical, measurable outcomes across medical, life sciences, automotive, and other advanced industries.
We’re an engineering company at heart—with over 75 engineers across our organization—and have built a legacy of over three decades of manufacturing excellence by doing what others consider impossible.
Position Overview: We are seeking a highly motivated Validation Engineer onsite at Cranberry Twp., Sturgeon, WI or Cranston, RI sites, to lead and support validation activities across multiple projects at our facility. This role is critical in ensuring compliance with regulatory standards (FDA, ISO 13485, 21 CFR Part 820), working closely with engineering, QA, and manufacturing teams. 
Key Responsibilities:
<ul>
<li>Develop and execute validation protocols. (IQ, OQ, PQ, TMV)</li>
<li>Maintain detailed validation documentation. (VMPs, reports, SOPs)</li>
<li>Conduct risk assessments and manage change controls.</li>
<li>Ensure regulatory compliance. (GMP, GLP, CSV, data integrity)</li>
<li>Collaborate cross-functionally to support validation strategy and training.</li>
<li>Monitor system performance and lead requalification activities.</li>
<li>Qualify suppliers and vendors.</li>
<li>Contribute to process improvements and continuous improvement initiatives.</li>
</ul>
Qualifications:
<ul>
<li>Bachelor’s in Engineering, Life Sciences, or related field.</li>
<li>3+ years' experience in validation or quality in a regulated industry.</li>
<li>Knowledge of FDA, ISO 13485, 21 CFR Part 820 standards.</li>
<li>Proficiency in Microsoft Suite; experience with validation software.</li>
<li>Strong communication, documentation, and analytical skills.</li>
<li>Preferred: Lean/Six Sigma certification; experience with LMS systems.</li>
</ul>
Work Environment: Split between office and production floor. Requires clear communication, computer use, and occasional physical movement around facility.
We are not offering sponsorship at this time for this position.

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