Quality Engineer – Medical Device (FDA 21 CFR 820)

Treace Medical Concepts, Inc.

Ponte Vedra Beach (FL)

On-site

USD 90,000 - 125,000

Full time

14 days+

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Job summary

Treace Medical Concepts, Inc. is seeking a Quality Engineer to drive quality projects in a fast-paced, FDA-compliant manufacturing environment. The QE will lead cross-functional efforts to maintain and improve quality systems and ensure on-time release of products.

Responsibilities include developing procedures, managing change controls, and supporting equipment qualification. A strong focus on risk management and supplier quality is required to sustain continuous improvement in our bunion

Qualifications

Bachelor’s degree in Engineering, Science, Technology or related field with 3+ years in medical device engineering.
Experience in FDA Title 21 CFR Part 820 environments and cross-functional settings.

Responsibilities

Create and update quality system procedures with cross-functional teams.
Evaluate product changes and disposition through change control.
Assemble non-sterile product into kits for final release.
Support setup, qualification, calibration, and maintenance of manufacturing/inspection equipment.
Create inspection models and documentation ensuring quality release.
Maintain risk management files to meet FDA/ISO standards.
Review non-conformances and propose quality system modifications.
Collaborate with supplier quality on corrective actions.