Hiring: Quality Engineer Company: Treace Medical Concepts, Inc. Location: Ponte Vedra Beach, FL Job Posted Time: 2026-09-10 11:20:38 Target Skills & Keywords : Quality Assurance, Risk Management About the job Experience: •3+ years of progressive medical device engineering experience (Manufacturing, Development or Quality Engineering) within an FDA compliant Title 21 section 820 environment Required Skills: •Creates and updates quality system procedures working on cross-functional teams to align best practices, procedures, and applicable regulations •Evaluates product changes and directs appropriate disposition of product through the company’s change control system •Assemble non-sterile product into kits for final release into the field •Participate in setup, qualification, calibration, and maintenance of manufacturing and inspection equipment •Lead and oversee creation of inspection models, inspection prints, gaging, or other inspection documents and detailed testing requirements to insure receipt of quality product •Support concurrent engineering efforts by participating in design development projects representing quality assurance and the customer (supplier and end user) •Lead and oversee creating and maintaining process risk management files to meet FDA and ISO standards •Reviews product and documentation non-conformances and recommends inspection, product and/or quality system modifications Qualifications: •All your information will be kept confidential according to EEO guidelines. •It is Treace’s policy not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, veteran status or any other characteristic protected by applicable law. EEO/Disabled/Veterans Employer •Treace is a drug free employer. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!