Johnson & Johnson MedTech · 18 hours ago
CAPA and NC Site Lead
Danvers, MA
Full-time
Onsite
Mid, Senior Level
$94K/yr - $152K/yr
5+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, focusing on preventing, treating, and curing complex diseases. The CAPA & Nonconformance Site Lead will optimize CAPA and Nonconformance processes in a regulated environment, ensuring compliance and driving quality improvements while mentoring junior engineers.
Hospital & Health Care
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
Qualification
Required
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
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
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
Technology
Engineering, and Math (STEM) Application
Technologically Savvy
Benefits
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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