Quality Engineer

Shape U.S. quality & regulatory strategy for a growing medical device start-up
High‑ownership role with global impact on patient health outcomes

About Our Client

Our client is a growing medical technology company pioneering advanced, patient‑specific implant solutions. The organization is backed by strong scientific expertise and global manufacturing capabilities, offering cutting‑edge innovation within a highly collaborative environment.

Job Description

Lead the U.S. Quality Management System ensuring alignment with FDA 21 CFR Part 820 and ISO 13485.
Act as the primary U.S. regulatory representative-managing FDA communications, responding to 483s, and coordinating inspections.
Oversee global suppliers, develop quality agreements, and maintain rigorous oversight of China‑based manufacturing partners.
Drive post‑market surveillance activities including complaint handling, adverse event reporting, and trend analysis.
Support design transfer, review DHFs/DMRs/DHRs, and evaluate design changes for 510(k) impact.
Conduct internal audits, maintain ISO certifications, and support regulatory submissions for global markets.
Lead process improvements using data-driven methodologies and ensure timely, effective CAPA execution.
Review batch records and test data for final release, and establish incoming inspection protocols.
Ensure import compliance, labeling accuracy, UDI/GUDID adherence, and proper establishment registrations.
Provide training, maintain documentation, and stay current on evolving regulatory and industry standards.

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

1-2+ years of experience in quality engineering within implantable or medical device manufacturing.
Strong working knowledge of FDA QSR, ISO 13485, ISO 14971, and U.S. import requirements.
Hands-on experience supporting FDA inspections and responding to regulatory findings.
Skilled in root-cause analysis, statistical tools, and risk‑based decision making.
Excellent communicator with the ability to collaborate cross‑functionally with global teams.
CQE or related certification is highly beneficial.
Ability to work independently in a contract-based, U.S.-leadership capacity.