Principal Engineer Quality

Location

Massachusetts, Westborough; nationwide workplace flexibility – remote work available.

Responsibilities

• Product Quality Leadership: Serve as the division’s primary partner and subject‑matter expert for end‑to‑end product quality; act as the escalation point for product quality issues, metrics, and risk management; provide QA leadership for Adverse Incident Reports (AIRs), Health Hazard Assessments/Field Corrective Actions (HHA/FCAs), and product escalations, assessing cross‑product or systemic impact; ensure alignment with 21 CFR Part 820, ISO 13485, and applicable global regulations.
• Corrective and Preventive Action (CAPA): Determine and implement robust corrective and preventive actions for product and process deficiencies; lead structured problem‑solving teams (e.g., 8D, DMAIC, root‑cause analysis) to resolve significant customer, product, and supplier complaints; oversee CAPA effectiveness checks and ensure sustainable systemic improvements.
• Nonconformance & Materials Review Board (MRB) Support: Support and lead the MRB in investigation and disposition of nonconforming materials (NCRs); drive timely resolution of product quality issues through cross‑functional collaboration.
• Risk Management & Process Controls: Facilitate and support cross‑functional execution of process flowcharts, PFMEAs, control plans, procedures and work instructions, and inspection data sheets; lead implementation and continuous improvement of quality systems and process controls; use data analysis and trending to identify emerging risks, assess failure modes, and recommend mitigation strategies.
• Design Transfer & Validation Oversight: Review and approve design transfer plans to ensure compliant transition from development to manufacturing; verify manufacturing specifications and instructions align with design outputs and product requirements; approve transfer documentation, including processes, quality‑control testing measures, and defined quality requirements; develop, oversee, review, and approve validation protocols and reports with statistical rigor and regulatory compliance.
• Metrics & Continuous Improvement: Establish and monitor key product quality metrics (e.g., complaint rates, failure trends, DPMO, CAPA effectiveness); analyze quality data to proactively identify systemic issues and drive improvement initiatives; present quality performance, risk assessments, and mitigation strategies to senior leadership.

Qualifications

• Bachelor’s degree in Engineering or a related technical field (required).
• 10+ years of product quality experience in the medical device industry or other regulated environment (required).
• Demonstrated experience with design transfer, process validation, CAPA systems, and complaint investigations (required).
• Experience leading cross‑functional problem‑solving teams (required).
• Strong working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and risk‑management principles (ISO 14971) (required).
• Strong analytical, statistical data‑analysis, and root‑cause investigation skills (required).
• Proven leadership, cross‑functional collaboration, and influence without direct authority (required).
• Excellent written and verbal communication skills (required).
• Ability to manage multiple priorities in a dynamic environment and travel regionally and internationally as needed (required).
• Advanced degree (preferred).

Benefits

• Competitive salary with annual bonus potential.
• 401(k) with company match.
• Comprehensive medical, dental, and vision coverage effective on start date.
• 24/7 Employee Assistance Program.
• Free live and on‑demand wellbeing programs.
• Generous paid vacation and sick time.
• Paid parental leave and adoption assistance.
• 12 paid holidays.
• On‑site child daycare, café, and fitness center (where available).
• Work‑life integrated culture with onsite, hybrid, and field work options.
• Paid volunteering and charitable donation/match programs.
• Employee Resource Groups and dedicated training resources.
• Paid educational assistance.

Pay

The anticipated base pay range for this full‑time position is $106,402 – $148,963 per year, plus potential for an annual bonus (subject to plan eligibility and other requirements). Compensation may vary based on location, experience, education, and certifications.