Staff Quality Systems Engineer

Johnson & Johnson•Cherry Hill, NJ

3d•Onsite

About The Position

Johnson & Johnson is seeking a Staff Quality Systems Engineer to lead and optimize CAPA and nonconformance (NC) processes in a regulated medical device environment. Based in Danvers, Massachusetts, the role supports quality system improvements, global regulatory compliance, and the development of junior engineers. It includes travel to support cross-site initiatives, supplier quality activities, and audit readiness; up to 10% travel may be required for inspections, audits, training, and collaboration with global teams. The engineer leads complex investigations of product and process nonconformances, oversees CAPA and NC execution, and serves as a subject matter expert during audits and regulatory assessments. The role also analyzes quality trends, supports risk management, works with cross-functional teams, and contributes to the ongoing improvement and harmonization of the Quality Management System.

Requirements

Bachelor’s degree in engineering, Life Sciences, or a related field.
At least 5–7 years of quality engineering or quality systems experience in the medical device industry.
Deep understanding of FDA QSR (21 CFR Part 820), ISO 13485, and EU MDR.
Proven experience managing CAPAs and nonconformances in a regulated environment.
Strong analytical skills and proficiency with quality tools such as 8D, FMEA, Six Sigma, and Lean.
Experience with electronic QMS platforms such as EtQ or SAP.
Excellent communication, leadership, and project management skills.

Nice To Haves

Advanced degree.
Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), Lean Six Sigma Black Belt, or similar certification.
Experience with complaint handling, design controls, and post-market surveillance.
Familiarity with global regulatory requirements such as USFDA, Health Canada, TGA, and PMDA.
Ability to influence cross-functional teams and drive quality culture.

Responsibilities

Lead complex investigations of product and process nonconformances using root cause analysis methodologies such as Fault Tree Analysis, 5 Whys, Fishbone, and DOE.
Oversee end-to-end CAPA and NC processes, ensuring timely execution, thorough documentation, and effective implementation of corrective and preventive actions.
Serve as a subject matter expert for CAPA and NC processes during internal audits, FDA inspections, and Notified Body assessments.
Analyze CAPA and NC trends and metrics to identify systemic issues and recommend quality improvements.
Collaborate with 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 QMS, including SOPs, work instructions, and templates.
Lead or support global harmonization initiatives for CAPA/NC processes across sites or business units.
Travel to support regulatory inspections and internal audits at other facilities, and training and collaboration with global teams.

Benefits

Company consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Vacation: 120 hours per calendar year.
Sick time: 40 hours per calendar year, with different amounts for employees residing in Colorado or Washington.
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, or foster care of a child.
Bereavement Leave: 240 hours for an immediate family member and 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.