Senior Quality Engineer - MedTech (Danvers/Woburn)

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

Job summary

Johnson & Johnson in Danvers, MA is seeking a Sr. Quality Engineer to support manufacturing and quality operations at the Danvers site, with additional support for the Woburn site. The role focuses on QA systems, CAPA, investigations, and process validations to uphold GMP, patient safety, and product quality.

The successful candidate will collaborate across functions, mentor team members, and drive continuous improvement in quality risks and nonconformances across multiple manufacturing areas.

Qualifications

• Bachelor's degree in Engineering or related field with 2-4 years of Quality Engineering experience.
• Solid understanding of IQ, OQ, PQ validation processes and GMP compliance.
• Ability to work independently and manage multiple tasks with proactive problem-solving.
• Strong communication skills and ability to mentor and lead teams.

Responsibilities

• Develop, modify, apply and maintain quality evaluation and control systems and protocols.
• Lead investigations of nonconformances and perform root cause analyses with CAPA.
• Coordinate with MRB for disposition decisions and monitor effectiveness of actions.
• Support process validations (IQ/OQ/PQ) and calibration/PM with equipment teams.
• Escalate quality issues promptly to management and ensure cross-site support.

Skills

Quality Engineering

Problem solving

Communication

Team leadership

Education

Bachelor's degree in Engineering or related field

ASQ Certified Quality Engineer (CQE)

Tools

SAP

Job description

Johnson & Johnson in Danvers, MA is seeking a Sr. Quality Engineer to support manufacturing and quality operations at the Danvers site, with additional support for the Woburn site. The role focuses on QA systems, CAPA, investigations, and process validations to uphold GMP, patient safety, and product quality.

The successful candidate will collaborate across functions, mentor team members, and drive continuous improvement in quality risks and nonconformances across multiple manufacturing areas.