Senior Quality Engineer, MedTech Manufacturing

Johnson & Johnson Co.; Danvers (MA); On-site; USD 79,000 - 128,000; Full time

Job summary

Johnson & Johnson in Danvers, MA, seeks a Sr. Quality Engineer to support operations at the Danvers and Woburn sites. You will drive quality engineering across manufacturing, including nonconformance, CAPA, process validation, and calibration.

The role emphasizes GMP compliance, IQ/OQ/PQ validation, and collaboration across teams to ensure patient safety and product quality. Medical device familiarity is a plus.

Qualifications

• Bachelor’s degree in Engineering or a related field.
• Solid understanding of IQ, OQ, PQ validation processes and GMP compliance.
• Proven ability to work independently and manage multiple tasks.
• Excellent problem‑solving skills and a proactive approach to challenges.
• Strong communication skills with the ability to mentor and lead teams.

Responsibilities

• Develop and maintain quality evaluation and control systems.
• Inspect and test production equipment for precision and accuracy.
• Design inspection processes and analyze testing mechanisms.
• Perform QA tests and statistical analysis to manage product quality risks.
• Lead root cause analysis and CAPA actions.
• Document production nonconformities and coordinate MRB disposition.
• Support CAPA from audits and monitor effectiveness.
• Coach team on non-conformance, corrective actions, and root cause analysis.

Skills

IQ/OQ/PQ validation

GMP knowledge

Problem solving

Communication skills

Mentoring teams

Education

Bachelor’s degree in Engineering

Tools

SAP

CQE certification

Job description

Johnson & Johnson in Danvers, MA, seeks a Sr. Quality Engineer to support operations at the Danvers and Woburn sites. You will drive quality engineering across manufacturing, including nonconformance, CAPA, process validation, and calibration.

The role emphasizes GMP compliance, IQ/OQ/PQ validation, and collaboration across teams to ensure patient safety and product quality. Medical device familiarity is a plus.