CAPA & NC Quality Systems Engineer – Med Devices

Regulatory Jobs; Danvers (MA); On-site; USD 96,000 - 155,000; Full time

Job summary

Johnson & Johnson in Danvers, MA is seeking a Staff Quality Systems Engineer to lead CAPA and Nonconformance in a regulated medical device environment. This role will be based in Danvers, MA.

The position focuses on driving quality system improvements, mentoring junior engineers, and ensuring compliance with FDA QSR, ISO 13485, and EU MDR. Travel to support cross-site initiatives is expected.

Qualifications

• Bachelor’s degree in engineering or life sciences; advanced degree preferred.
• 5–7 years in quality engineering or quality systems in the medical device industry.
• Knowledge of FDA QSR, ISO 13485, and EU MDR.
• Experience managing CAPAs and NCs in regulated environments.
• Proficient with quality tools (8D, FMEA, Six Sigma, Lean).
• Experience with electronic QMS platforms (EtQ, SAP).

Responsibilities

• Lead investigations of product and process nonconformances using root cause analysis methods.
• Oversee the CAPA and NC process end-to-end, ensuring timely actions and proper documentation.
• Serve as SME for CAPA/NC during internal audits, FDA inspections, and Notified Body assessments.
• Analyze CAPA/NC trends to identify systemic issues and suggest improvements.
• Collaborate with cross-functional teams to resolve quality issues and implement sustainable solutions.
• Support risk management activities per ISO 14971, including risk assessments.
• Mentor junior engineers on CAPA/NC processes and regulatory requirements.
• Contribute to developing and improving the QMS, SOPs, and templates.
• Lead or support global CAPA/NC harmonization across sites.
• Travel up to 10% for regulatory inspections and cross-site collaboration.

Skills

Quality engineering

FDA knowledge

Leadership

Project management

Quality tools

Education

Bachelor’s degree in engineering or Life Sciences

Advanced degree preferred

Tools

EtQ

SAP

Job description

Johnson & Johnson in Danvers, MA is seeking a Staff Quality Systems Engineer to lead CAPA and Nonconformance in a regulated medical device environment. This role will be based in Danvers, MA.

The position focuses on driving quality system improvements, mentoring junior engineers, and ensuring compliance with FDA QSR, ISO 13485, and EU MDR. Travel to support cross-site initiatives is expected.