Job Summary:

We are seeking a highly experienced CAPA & Nonconformance Site Leadto 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:

• Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree preferred.

• Minimum 5–7 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., EtQ,SAP).

• 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.

Required Skills:

Preferred Skills: