Quality Engineer

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.

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