CAPA and NC Site Lead
About The Position
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity, and innovation. CAPA & Non Conformance Site Lead (Danvers) 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.
Requirements
- 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.
Nice To Haves
- 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.
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.
Benefits
- employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company’s long-term incentive program.
- 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 period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
