Senior Quality Engineer Position Available In Middlesex, New Jersey

Key Responsibilities Quality Systems & Compliance Maintain and continuously improve Quality Systems in alignment with

FDA 21 CFR

Part 820 , ISO 13485 , and MDSAP requirements. Oversee quality planning, document control, internal audits, inspection procedures, change management, and CAPA processes. Risk Management & Process Validation Lead the development of PFMEAs , Control Plans , and other risk analysis tools for new and existing products. Plan and execute validation activities ( IQ/OQ/PQ ) for processes, equipment, and test methods in compliance with regulatory standards. Design Transfer & Production Support Review and approve Engineering Change Orders (ECOs) , Manufacturing Variances (MVs) , and process documentation. Support new product introduction (NPI) initiatives and major process changes with robust quality planning. Quality Monitoring & Continuous Improvement Analyze production and field return data to identify trends, root causes, and improvement opportunities. Participate in or lead Product Line Quality Committees (PLQCs) to drive process enhancements and product reliability. Generate reports on non-conformances, CAPAs, and other quality metrics; present findings to cross-functional teams. Problem Solving & CAPA Management Lead or support investigations and root cause analyses; drive effective corrective and preventive actions. Utilize statistical tools ( SPC , Minitab , etc.) to support data-driven decision making. Qualifications Deep understanding of

FDA 21 CFR

Part 820 , ISO 13485 , and MDSAP requirements. Demonstrated experience in validation (IQ/OQ/PQ) , PFMEAs , risk analysis , and quality planning . Proficient in data analysis , SPC , and report generation using tools such as Minitab or similar. Skilled in inspection techniques, sampling plans, and quality control procedures. Strong interpersonal, communication, and cross-functional collaboration skills. Proficiency in Microsoft Office Suite (Word, Excel, Access); experience with Power BI , MasterControl , or other quality systems is a plus. Six Sigma Green Belt and internal auditing experience are highly desirable. Education & Experience Bachelor’s degree in Engineering , Life Sciences , or a related technical field. Minimum of 6+ years of experience in Quality Engineering within a regulated medical device or IVD industry, or 2+ years at a senior level.