Senior Quality Engineer, MedTech (Life-Saving Devices)

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

Benefits offered by this job

Vacation – 120 hours/year

Sick time – 40 hours/year

Holiday pay – 13 days/year

Parental Leave – 480 hours/year

Volunteer Leave – 32 hours/year

Job summary

Johnson & Johnson is seeking a Sr. Quality Engineer to support manufacturing of life-saving medical devices at the Danvers, MA and Woburn, MA sites. You will drive quality systems, risk assessment, and continuous improvement to ensure product safety and regulatory compliance.

The role requires 2–4 years in quality engineering, proficiency with IQ/OQ/PQ validation, and a proactive, collaborative approach across functions. This position is based in Massachusetts with cross-site responsibilities.

Qualifications

• Bachelor’s degree in Engineering or a related technical field and 2–4 years of relevant Quality Engineering experience.
• Solid understanding of IQ, OQ, PQ validation processes and GMP compliance.
• Ability to work independently and manage multiple tasks effectively.
• Excellent problem-solving and a proactive approach to challenges.
• Strong communication and leadership abilities.

Responsibilities

• Develop and maintain quality evaluation and control systems and protocols.
• Define inspection, testing and evaluation processes for products and equipment; analyze quality risks.
• Conduct root cause analysis and implement corrective actions.
• Provide QA support for both Danvers and Woburn sites and CAPA programs.
• Collaborate with MRB, CAPA, calibration, validations, and non-conformances across manufacturing and quality operations.

Skills

Independent work

Problem solving

Communication

Leadership

Education

Bachelor's degree in Engineering or related field

Tools

SAP

Job description

Johnson & Johnson is seeking a Sr. Quality Engineer to support manufacturing of life-saving medical devices at the Danvers, MA and Woburn, MA sites. You will drive quality systems, risk assessment, and continuous improvement to ensure product safety and regulatory compliance.

The role requires 2–4 years in quality engineering, proficiency with IQ/OQ/PQ validation, and a proactive, collaborative approach across functions. This position is based in Massachusetts with cross-site responsibilities.