Senior Quality Engineer, MedTech GMP — Patients First

NCSL International; 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 the manufacturing of life-saving medical devices. Based in Danvers or Woburn, you will uphold high quality standards, compliance and patient safety across functions.

Responsibilities include CAPA, audits, nonconformances, root cause analysis, and coordinating with equipment and incoming inspection. The role requires a Bachelor's in Engineering and 2–4 years of Quality Engineering experience, with GMP and FDA/regulatory

Qualifications

• Solid understanding of IQ, OQ, PQ validation processes and GMP compliance.
• Ability to work independently and manage multiple tasks.
• Excellent problem-solving and proactive approach to challenges.
• Strong communication skills and ability to mentor and lead teams.

Responsibilities

• Document production nonconformity, investigate, assess risk and disposition with MRB.
• Define and implement CAPA plans and effectiveness monitoring from audits.
• Coach team on quality non-conformance, root cause analysis, and corrective actions.
• Escalate quality issues to management promptly.
• Identify non-conformances under limited supervision and implement corrective actions.
• Support process validations/revalidation (IQ/OQ/PQ).
• Support incoming inspection as needed.
• Collaborate with equipment team on PM and calibration updates, and address non-conformities.

Skills

Quality Engineering

Problem solving

Communication

Leadership

Education

Bachelor's degree in Engineering or related field

Tools

SAP

Job description

Johnson & Johnson in Danvers, MA seeks a Sr. Quality Engineer to support the manufacturing of life-saving medical devices. Based in Danvers or Woburn, you will uphold high quality standards, compliance and patient safety across functions.

Responsibilities include CAPA, audits, nonconformances, root cause analysis, and coordinating with equipment and incoming inspection. The role requires a Bachelor's in Engineering and 2–4 years of Quality Engineering experience, with GMP and FDA/regulatory