Quality Engineer

Treace; Ponte Vedra Beach (FL); On-site; USD 75,000 - 110,000; Full time

Job summary

Treace is seeking a Quality Engineer to drive quality projects in a FDA Title 21 CFR 820 environment, primarily supporting in-house manufacturing. The role requires collaboration across functions to ensure compliant processes, robust documentation, and accelerated product release.

Qualifications include a Bachelor's in Engineering and 3+ years in medical device engineering, with hands-on experience in quality systems, change control, and risk management.

Qualifications

• Bachelor's degree in Engineering, Science, Technology or related discipline with 3+ years of medical device experience.
• Experience in FDA Title 21 CFR 820 compliant environments.

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.
• Set up, qualify, calibrate, and maintain manufacturing and inspection equipment.
• Create inspection models, prints, gaging, and testing requirements.
• Support design development projects representing QA and customer.
• Maintain process risk management files to meet FDA/ISO standards.
• Review non-conformances and recommend QA modifications.
• Interface with supplier quality on corrective actions.
• Assist in inspection of work-in-progress and final release paperwork.
• Review patient-specific instrumentation designs.
• Promote Continuous Improvement and Lean culture.

Skills

Quality engineering

Medical devices

FDA 21 CFR 820

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

Inspection equipment

Job description

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 Description

POSITION 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

Qualifications

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 Information

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.