CAPA and NC Site Lead (mfd)

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Job Title: CAPA & Nonconformance Site Lead (Aachen)

Job Summary:

We are seeking a highly experienced CAPA & Nonconformance Site Lead to lead and optimize CAPA and Nonconformance (NC) processes within a regulated medical device environment. This role is instrumental in driving quality system improvements ensuring global regulatory compliance and mentoring junior engineers. The position includes travel to support cross-site initiatives supplier quality activities and audit readiness.

Key Responsibilities:

• Lead complex investigations of product and process nonconformances using advanced root cause analysis methodologies (e.g. Fault Tree Analysis 5 Whys Fishbone DOE).

• Oversee the end-to-end CAPA and NC process ensuring timely execution thorough documentation and effective implementation of corrective and preventive actions.

• Serve as a subject matter expert (SME) for CAPA and NC processes during internal audits FDA inspections and Notified Body assessments.

• Analyze CAPA/NC trends and metrics to identify systemic issues and recommend strategic quality improvements.

• Collaborate with cross-functional teams including Manufacturing R&D Regulatory Affairs and Supplier Quality to resolve quality issues and implement sustainable solutions.

• Support risk management activities in accordance with ISO 14971 including risk assessments related to CAPAs and NCs.

• Mentor and train junior quality engineers and other stakeholders on CAPA/NC processes regulatory requirements and quality tools.

• Contribute to the development and continuous improvement of the Quality Management System (QMS) including SOPs work instructions and templates.

• Lead or support global harmonization initiatives for CAPA/NC processes across multiple sites or business units.

Travel Requirements:

• Up to 10% travel may be required to support:

• • Regulatory inspections and internal audits at other facilities

  • Training and collaboration with global teams

Qualifications:

• Bachelors degree in Engineering Life Sciences or related field; advanced degree preferred.

• Minimum 57 years of experience in quality engineering within the medical device industry.

• Deep understanding of FDA QSR (21 CFR Part 820) ISO 13485 and EU MDR.

• Proven experience managing CAPAs and NCs in a regulated environment.

• Strong analytical skills and proficiency in quality tools (e.g. 8D FMEA Six Sigma Lean).

• Experience with electronic QMS platforms (e.g. EtQSAP).

• Excellent communication leadership and project management skills.

Preferred Skills:

• Certified Quality Engineer (CQE) Certified Manager of Quality/Organizational Excellence (CMQ/OE) or similar.

• Experience with complaint handling design controls and post-market surveillance.

• Familiarity with global regulatory requirements (e.g. USFDA Health Canada TGA PMDA).

• Ability to influence cross-functional teams and drive quality culture.

The anticipated base pay range for this position is 75.000 EUR to 118.450 EUR.

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