Quality Systems Engineer (Medical Devices)

Location: Devens, MA, United States

Annual base salary: $75,413–$103,692, plus equity and comprehensive benefits.

Company

Develops and operates industrially scalable laser metal additive manufacturing and precision machining capabilities for aerospace, defense, medical, and other essential industries.

What you will do

• Establish and maintain the quality management system in accordance with applicable regulatory requirements.
• Write, review, approve, and update QMS procedures and documentation changes.
• Support NCR, CAPA, internal audit, management review, and QMS training programs.
• Track and trend quality metrics and KPIs, including CAPAs, nonconformances, SCARs, complaints, deviations, audit findings, and calibration.
• Lead or support quality system projects and develop practical solutions for complex process and compliance issues.
• Coordinate audit and inspection preparation, resolution tracking, and escalation of compliance risks.

Requirements

• 3+ years of experience in the medical device or aerospace industries.
• Knowledge of FDA regulatory requirements, ISO 13485, AS9100, and/or ISO 9001.
• Experience writing QMS procedures and working with NCR and CAPA processes.
• Experience evaluating quality metrics and KPIs.
• Strong communication, interpersonal, and leadership skills.

Nice to have

• Experience in startups.
• Experience supporting audits.
• Experience leading and influencing cross-functional groups and leadership levels.

Culture & Benefits

• Inclusive culture focused on ownership, curiosity, accountability, and continuous learning.
• Medical, dental, vision, and life insurance.
• Generous paid time off.
• 401(k) plan with company match.
• Competitive equity package.