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1 result for Compliance in Woodbridge, NJ
- West Windsor, NJ
- onsite
- Permanent / Full Time
- 90000 - 115000 USD / Yearly
- <p>Benefits:</p><ul><li>medical</li><li>dental insurance</li><li>vision care</li><li>401k plan</li><li>paid time off</li></ul><p>Responsibilities</p><ul><li>Support the development, maintenance, and continuous improvement of quality systems within a regulated medical device environment. </li><li>This role will be responsible for ensuring compliance with FDA Quality Management System Regulations (QMSR), ISO 13485, and EU Medical Device Regulation (MDR) requirements. </li><li>Maintain and improve the Quality Management System (QMS) to ensure compliance with FDA QMSR, ISO 13485, and EU MDR requirements.</li><li>Support product development activities by participating in design reviews, risk management, verification and validation, and design control processes.</li><li>Review and approve quality system documentation, including procedures, work instructions, specifications, and records.</li><li>Lead or support investigations involving nonconformances, complaints, deviations, CAPAs, and root cause analysis.</li><li>Partner with Engineering, Manufacturing, Regulatory Affairs, and Operations teams to ensure quality requirements are effectively implemented.</li><li>Support internal, supplier, customer, and regulatory audits, including audit preparation, response coordination, and corrective action implementation.</li></ul>
- 2026-10-22T00:00:00Z