Treace’s mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty® System as the standard of care. We are committed to operating our business with the highest standards of ethical conduct. We intend to exceed our customers’ expectations through an innovation-driven, high-velocity approach to solving treatment and surgical problems. With our products and services, our mission is to assist foot and ankle surgeons in improving patient outcomes and reducing healthcare costs, while providing rewarding experiences and opportunities for our employees and stakeholders.
Job DescriptionPOSITION SUMMARY:
The Quality Engineer (QE) will be responsible for management and execution of assigned quality projects in order to meet quality assurance objectives. The QE shall have prior experience working within an FDA compliant Title 21 section 820 environment and the ability to work cross-functionally to support rapid growth and continuous improvement. This position primarily will support in-house manufacturing operations.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Creates and updates quality system procedures working on cross-functional teams to align best practices, procedures, and applicable regulations (FDA, ISO, etc.)
- 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
- Responsible for 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)
- Responsible for 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
- Interfaces with supplier quality representatives concerning issues with quality assurance and assures that effective corrective action is implemented
- Assists in inspection of work-in-progress, finished parts and assemblies, kits and completion of associated paperwork for final release of product
- Assists in reviewing patient-specific instrumentation designs
- Participates in projects and help drive and build a Continuous Improvement and Lean culture across the organization
MINIMUM REQUIREMENTS:
Education and Experience: Bachelor's degree in Engineering, Science, Technology or a related discipline with 3+ years of progressive medical device engineering experience (Manufacturing, Development or Quality Engineering) within an FDA compliant Title 21 section 820 environment
Additional InformationAll your information will be kept confidential according to EEO guidelines.
Treace's Privacy Policy
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.
Skills Required
- Bachelor's degree in Engineering, Science, Technology, or related discipline
- 3+ years progressive medical device engineering experience (Manufacturing, Development or Quality Engineering)
- Experience working within an FDA compliant Title 21 CFR 820 environment
- Knowledge of FDA and ISO quality system standards
- Experience with change control, product disposition, and non-conformance review
- Experience with inspection methods, gaging, calibration, and equipment qualification
- Ability to work cross-functionally and support in-house manufacturing operations
Treace Medical Concepts Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Treace Medical Concepts and has not been reviewed or approved by Treace Medical Concepts.
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Healthcare Strength — Health coverage includes multiple tiers of medical plans alongside dental insurance, with the core package often characterized as solid. This breadth points to a dependable foundation for medical and dental needs.
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Retirement Support — A 401(k) with company match is available, and corporate filings confirm a sponsored plan. This provides a clear vehicle for long‑term savings.
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Leave & Time Off Breadth — PTO, paid holidays, and maternity/paternity leave are offered, and several sources describe PTO and parental leave as generous. This mix supports time away for both rest and family needs.
Treace Medical Concepts Insights
What We Do
Treace Medical Concepts, Inc. is a medical technology company with the goal of advancing the standard of care for the surgical management of bunion deformities and related midfoot correction. Bunions are complex 3-dimensional deformities that originate from an unstable joint in the middle of the foot and affect approximately 67 million Americans1, of which Treace estimates 1.1 million are annual surgical candidates. Treace Medical has pioneered and patented the Lapiplasty® 3D Bunion Correction® system – a combination of instruments, implants, and surgical methods designed to surgically correct all 3 planes of the bunion deformity and secure the unstable joint, addressing the root cause2,3 of the bunion. At Treace Medical Concepts, Inc., our mission is to advance the standard of care for the surgical management of bunions and related midfoot deformities. Treace Medical offers the Adductoplasty® System, the Hammertoe PEEK Fixation System, the SpeedPlate™ System, and other ancillary The content herein is for informational purposes and intended for healthcare professionals only. Treace Medical Concepts, Inc. does not dispense medical advice. A surgeon should rely on his or her own professional clinical judgment when deciding whether to use a specific product when treating a particular patient. Prior to use of the device, the surgeon should refer to the instructions for use for complete indications, contraindications, warnings, and risks. Complete risk and benefit information: www.treace.com. Visit www.treace.com/privacy-policy for our Privacy Policy. Treace Medical will make an offer of employment only to individuals who have applied for a position using our official application. Be on alert for possible fraudulent offers of employment. Treace Medical will not solicit money or banking information from applicants.
