Senior Quality Engineer - Medical Devices & Compliance

Manpower Group (USA); Wayne (NJ); On-site; USD 67,000 - 91,000; Full time

Job summary

Our client, a leading organization in the medical device industry, is seeking a dedicated and detail-oriented Quality Engineer to join their team in East Windsor, New Jersey. The role focuses on ensuring regulatory compliance and leading design control activities to deliver safe, effective medical devices.

You will develop test protocols, support cross-functional teams with failure investigations and CAPA, and maintain Design History Files with meticulous attention to documentation and

Qualifications

• Bachelor's degree in engineering, science, or related field is required.
• Minimum of 7 years' experience in quality or engineering in the medical device/pharma space.
• Experience with Class III disposable and/or electro-mechanical devices is preferred.
• Strong knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDD and EU MDR regulations.
• Excellent analytical, problem-solving, and communication skills; team collaboration ability.

Responsibilities

• Ensure design control activities including planning, risk management, verification/validation and design reviews.
• Develop and execute test protocols, reports, and data analyses for quality and compliance.
• Provide quality engineering support to cross-functional teams including CAPA and failure investigations.
• Maintain and update Design History Files with accurate documentation and regulatory compliance.

Skills

Analytical thinking

Communication skills

Problem-solving

Cross-functional collaboration

Education

Bachelor's degree in engineering, science, or related field

Job description

Our client, a leading organization in the medical device industry, is seeking a dedicated and detail-oriented Quality Engineer to join their team in East Windsor, New Jersey. The role focuses on ensuring regulatory compliance and leading design control activities to deliver safe, effective medical devices.

You will develop test protocols, support cross-functional teams with failure investigations and CAPA, and maintain Design History Files with meticulous attention to documentation and