Senior CAPA & NC Quality Systems Engineer

Biopharma Asia; 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, based in Danvers.

You will drive quality system improvements, ensure global regulatory compliance, mentor junior engineers, and collaborate with cross-functional teams across Manufacturing, R&D, Regulatory Affairs and Supplier Quality. Travel up to 10% may be required.

Qualifications

• Bachelor's degree in engineering, life sciences, or related field; advanced degree preferred.
• 5–7 years of quality engineering in the medical device industry.
• Deep understanding of FDA QSR (21 CFR Part 820), ISO 13485.
• Proven experience managing CAPAs and NCs in a regulated environment.
• Experience with electronic QMS platforms (EtQ, SAP).
• Certified Quality Engineer (CQE) or CMQ/OE preferred.

Responsibilities

• Lead complex investigations of product and process nonconformances using RCA methodologies (FTA, 5 Whys, Fishbone, DOE).
• Oversee end-to-end CAPA and NC process with timely execution and 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 improvement opportunities.
• Collaborate with Manufacturing, R&D, Regulatory Affairs, and Supplier Quality to resolve issues.
• Support risk management per ISO 14971 including CAPA/NC risk assessments.
• Mentor and train junior quality engineers on CAPA/NC and regulatory requirements.
• Contribute to QMS development and SOP/templates improvement.
• Lead or support global CAPA/NC harmonization initiatives across sites.
• Travel up to 10% for regulatory inspections and internal audits.

Skills

CAPA management

Root-cause analysis

Quality systems

QMS

Six Sigma

Lean

Project management

Leadership

Education

Bachelor's degree in Engineering

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, based in Danvers.

You will drive quality system improvements, ensure global regulatory compliance, mentor junior engineers, and collaborate with cross-functional teams across Manufacturing, R&D, Regulatory Affairs and Supplier Quality. Travel up to 10% may be required.