Quality Engineer

Job Title: Quality Engineer
Location: Wayne, NJ
Pay Rate: $50 per hour
Our client, a leading medical device company, is seeking a Quality Engineer II to join their Product Development and Engineering team. This critical role ensures the quality and compliance of medical devices throughout the product development lifecycle. You will collaborate with cross-functional teams to identify risks, implement quality controls, and ensure compliance with industry regulations and standards.
What You’ll Be Doing:

• Ensure product development and design changes follow Design Control procedures and regulatory standards (ISO 13485, FDA 21 CFR Part 820, EU MDD, EU MDR).
• Develop and implement quality plans, procedures, and protocols.
• Participate in design reviews, risk assessments, and FMEA activities.
• Collaborate with engineering teams to integrate quality into product design.
• Support design verification and validation (V&V), including protocols and reports.
• Maintain and manage risk management files throughout the product lifecycle.
• Proactively identify and address quality and compliance risks.

What You Bring:

• Bachelor’s degree in Engineering, Science, or related field.
• 5+ years of experience in Quality or Engineering, preferably in the medical device or pharmaceutical industry.
• Experience with Class III disposable and/or electro-mechanical medical devices is a plus.
• Knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDD/MDR, with expertise in Design Controls and Risk Management.
• Familiarity with sampling plans, DHF setup, and design trace matrices.
• Certifications such as ASQ CQE or Six Sigma Green Belt are a plus.
• Strong skills in Microsoft Office (Word, Excel, etc.).
• Project management and leadership experience are desirable.

If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
About ManpowerGroup, Parent Company of:  Manpower, Experis, Talent Solutions, and Jefferson Wells
ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent