Staff Quality Systems Engineer — CAPA & NC Leader

Johnson & Johnson Co.; Danvers (MA); On-site; USD 96,000 - 155,000; Full time

Job summary

Johnson & Johnson is seeking a Staff Quality Systems Engineer in Danvers, MA to lead CAPA and NC processes in a regulated medical device environment. You will mentor engineers, drive quality improvements, and support regulatory readiness across sites.

The role requires deep FDA QSR, ISO 13485, and EU MDR knowledge, with up to 10% travel for inspections and cross-site initiatives. Base pay reflects a broad range of benefits and a strong quality culture.

Qualifications

• Bachelor’s degree in engineering, life sciences, or related field; advanced degree preferred.
• Minimum 5–7 years of quality engineering/quality systems experience in medical devices.
• Strong knowledge of FDA QSR, ISO 13485, and EU MDR.
• Experience managing CAPA and NCs in regulated environments.
• Proficiency with quality tools (8D, FMEA, Six Sigma, Lean).
• Experience with electronic QMS platforms such as EtQ and SAP.

Responsibilities

• Lead complex investigations of product and process nonconformances using root cause analysis.
• Oversee end-to-end CAPA and NC processes with proper documentation.
• Serve as SME for CAPA/NC during audits and inspections.
• Analyze CAPA/NC trends and drive quality improvements.
• Collaborate with Manufacturing, R&D, Regulatory Affairs, and Supplier Quality.
• Support risk management per ISO 14971, including risk assessments.
• Mentor junior quality engineers on CAPA/NC processes and regulatory requirements.
• Contribute to development and improvement of the QMS and SOPs.
• Support global harmonization of CAPA/NC across sites.

Skills

CAPA management

Root cause analysis

Regulatory knowledge

Cross-functional leadership

Education

Bachelor’s degree in engineering, Life Sciences, or related field

Tools

EtQ

SAP

Job description

Johnson & Johnson is seeking a Staff Quality Systems Engineer in Danvers, MA to lead CAPA and NC processes in a regulated medical device environment. You will mentor engineers, drive quality improvements, and support regulatory readiness across sites.

The role requires deep FDA QSR, ISO 13485, and EU MDR knowledge, with up to 10% travel for inspections and cross-site initiatives. Base pay reflects a broad range of benefits and a strong quality culture.