New Jersey Staffing
Quality Engineer II
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. We look forward to speaking with you!
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. We look forward to speaking with you!