Quality Assurance
Robert Half · West Windsor, NJ · 3 days ago
On-siteQuality AssuranceFull-time
Benefits:medicaldental insurancevision care401k planpaid time offResponsibilitiesSupport the development, maintenance, and continuous improvement of quality systems within a regulated medical device environment. This role will be responsible for ensuring compliance with FDA Quality Management System Regulations (QMSR), ISO 13485, and EU Medical Device Regulation (MDR) requirements. Maintain and improve the Quality Management System (QMS) to ensure compliance with FDA QMSR, ISO 13485, and EU MDR requirements.Support product development activities by participating in design reviews, risk management, verification and validation, and design control processes.Review and approve quality system documentation, including procedures, work instructions, specifications, and records.Lead or support investigations involving nonconformances, complaints, deviations, CAPAs, and root cause analysis.Partner with Engineering, Manufacturing, Regulatory Affairs, and Operations teams to ensure quality requirements are effectively implemented.Support internal, supplier, customer, and regulatory audits, including audit preparation, response coordination, and corrective action implementation. 3+ years of experience in Quality Management within a medical device manufacturing environment. The ideal candidate will have experience supporting medical device products, including software-enabled devices, and a strong understanding of quality and regulatory requirements throughout the product lifecycle. Robert Half is the world’s first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles. Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity - whenever you choose - even on the go. Download the Robert Half app and get 1-tap apply, notifications of AI-matched jobs, and much more. All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information. © 2025 Robert Half. An Equal Opportunity Employer. M/F/Disability/Veterans. By clicking “Apply Now,” you’re agreeing to Robert Half’s Terms of Use and Privacy Notice.