Senior Quality Engineer - Implantable Devices - Boston, MA

Quality Management System Specialist

Be the sole US quality voice for FDA-cleared specialty medical devices. Own global quality oversight with real FDA visibility.

About Our Client

Our client is a well-funded, Boston-area medical device company operating at the intersection of advanced manufacturing and patient-specific healthcare solutions. With a strong international footprint and a mission-driven culture, they are scaling innovative technologies that directly improve patient outcomes.

Job Description

• Establish, maintain, and continuously improve a compliant Quality Management System aligned with FDA QMSR and ISO 13485
• Serve as the primary US contact for the FDA, including inspection readiness, responses to 483s, and regulatory correspondence
• Lead oversight of international manufacturing partners through audits, quality agreements, and performance monitoring
• Own post-market surveillance activities including complaints, adverse events, trending, and CAPA effectiveness
• Review and approve DHF, DMR, and DHR documentation during design transfer and ongoing production
• Assess design and process changes for regulatory impact and determine 510(k) submission strategy
• Oversee supplier qualification, scorecards, corrective actions, and ongoing compliance
• Ensure import, labelling, UDI, and establishment registration compliance for US market access
• Perform final batch release reviews and establish incoming inspection controls
• Drive continuous improvement through data analysis, audits, and supplier engagement

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state, or local law. MPI encourages applications from minorities, women, the disabled, protected veterans, and all other qualified applicants.

The Successful Applicant

• Experience supporting quality systems for implantable medical devices
• Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, and related regulations
• Hands-on experience preparing for and supporting FDA inspections
• Background working with international or offshore manufacturing partners
• Proven capability in CAPA, root cause analysis, and risk management
• Excellent communication skills with the confidence to operate independently
• CQE or similar certification preferred but not required

What's on Offer

• You'll have full ownership of US quality and regulatory activities
• Direct exposure to the FDA and global regulatory strategy
• High-impact role with executive visibility and autonomy
• Work on cutting-edge, patient-specific implant technology
• Join a growing organization with strong funding and long-term vision

Job Summary

Sector: Engineering & Manufacturing

Sub Sector: Quality, Technical

Industry: Industrial / Manufacturing

Where: Watertown

Contract Type: Permanent

Consultant name: Taylor Rankin

Job Reference: JN-022026-6951107