Job Description
Validation & Engineering Group, Inc. (V&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:
Quality Engineer
The Quality Engineer – Medical Devices supports the design, development, and launch of new medical device projects by ensuring that all activities comply with ISO 13485, FDA 21 CFR Part 820 , and applicable regulatory requirements.
This role focuses on implementing quality systems, risk management, and validation activities that ensure product safety, performance, and compliance from concept through commercialization.
Key Responsibilities
Project & Design Quality
Partner with R&D and Engineering teams during new product introduction (NPI) to ensure design control requirements are met.
Support Design History File (DHF) documentation, including Design Inputs, Verification/Validation, and Design Reviews.
Perform and document risk management activities (FMEA, PFMEA, hazard analysis) according to ISO 14971.
Review and approve engineering change orders (ECOs) and technical documentation.
Participate in design transfer to manufacturing and ensure readiness for production.
Validation & Process Quality
Develop and execute IQ/OQ/PQ protocols for manufacturing equipment, test systems, and processes.
Support process capability studies, Gage R&R, and statistical analysis for validation.
Review and approve supplier qualifications, component inspections, and process controls.
Ensure compliance with GMP, ISO 13485, and corporate QMS procedures.
Quality Systems & Continuous Improvement
Support CAPA investigations and implement effective corrective and preventive actions.
Contribute to internal and supplier audits and manage audit findings closure.
Analyze nonconformance and complaint data to identify trends and drive improvement.
Support documentation updates and training related to new products and processes.
Qualifications
Education
Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, or related discipline).
Experience
Minimum 5 years of experience in a Quality Engineering role within the Medical Device industry .
Strong knowledge of ISO 13485 , 21 CFR Part 820 , and ISO 14971 .
Experience in new product introduction (NPI) or project-based environments .
Hands-on experience with validation protocols , FMEA , and root cause analysis tools.
Skills
Proficient in statistical tools (Minitab, JMP, Excel).
Excellent documentation and communication skills.
Strong understanding of IQ/OQ/PQ, GMP, design control, and risk management principles.
Team-oriented, adaptable, and organized in fast-paced project environments.
Preferred
Six Sigma Green Belt or equivalent experience in process improvement.
Experience with combination products or Class II / III medical devices.
Familiarity with supplier quality and auditing processes.
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