Staff Quality Systems Engineer

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

• 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.

$96,000.00 - $155,250.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 For additional general information on Company benefits, please go to

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