Job Description

Job Description

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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