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# Staff Quality Systems Engineer

- **Company:** Johnson & Johnson
- **Location:** Danvers, MA, United States
- **Experience:** Expert
- **Salary:** $96,000 - $155,250
- **Contract:** Permanent contract
- **Skills:** Failure Mode Effects Analysis, SAP (Applications)
- **Published:** November 5, 2026
- **Apply:** https://www.jobmonkeyjobs.com/career/28161662/Staff-Quality-Systems-Engineer-Massachusetts-Danvers-1306

## About the Role

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

## Description

We are searching for the best talent for a Staff Quality Systems Engineer to lead and optimize CAPA and Nonconformance (NC) processes within a regulated medical device environment. This role will be based in Danvers, MA.

Purpose: 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.

You will be responsible for:

 * 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.
 * Up to 10% travel may be required to support:
 + Regulatory inspections and internal audits at other facilities
 + Training and collaboration with global teams