Sr. Quality Engineer

Senior Quality Engineer role supporting medical device manufacturing at Johnson & Johnson's Danvers and Woburn, Massachusetts facilities. Responsible for developing quality systems, conducting process validations, managing nonconformances, and ensuring GMP compliance across manufacturing and quality operations.

Responsibilities

• Develop, modify, and maintain quality evaluation and control systems, inspection protocols, and testing procedures
• Conduct root cause analysis of incidents, document nonconformities, assess product risk, and recommend disposition
• Define and implement corrective and preventive action plans with effectiveness monitoring from audits
• Support process validations and revalidations (IQ, OQ, PQ) for current and new manufacturing processes
• Collaborate with equipment and incoming inspection departments on calibration, maintenance procedures, and nonconformity resolution

Requirements

• Bachelor's degree in Engineering or related technical field
• 2–4 years of Quality Engineering or related experience
• Solid understanding of IQ, OQ, PQ validation processes and GMP compliance
• Proven ability to work independently and manage multiple tasks effectively
• Strong problem-solving and communication skills with team mentoring capability
• Knowledge of medical device industry and FDA 21 CFR Part 820 regulations (preferred)