CAPA and NC Site Lead

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Job Function:
Supply Chain Engineering

Job Sub     Function:
Quality Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Danvers, Massachusetts, United States of America

Job Description:

CAPA & Nonconformance Site Lead (Aachen)

Job Summary:

We are seeking 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:

Bachelor's degree in engineering, Life Sciences, or related field; advanced degree preferred.

Minimum 5-7 years of experience in quality engineering /quality systems 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), Lean Six Sigma Black Belt 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.

Required Skills:

Preferred

Skills:

Coaching, Consistency, Controls Compliance, Critical Thinking, Data Savvy, Engineering, Financial Competence, Good Automated Manufacturing Practice (GAMP), ISO 9001, Lean Supply Chain Management, Leverages Information, Process Improvements, Quality Control (QC), Quality Standards, Quality Systems Documentation, Quality Validation, Science,…