Quality Engineer

About the role

Treace is committed to operating with the highest standards of ethical conduct and exceeding customer expectations through an innovation-driven, high-velocity approach. The Quality Engineer (QE) will manage and execute assigned quality projects to meet quality assurance objectives within an FDA-compliant Title 21 section 820 environment, supporting in-house manufacturing operations and cross-functional teams to drive rapid growth and continuous improvement.

Responsibilities

• Creates and updates quality system procedures, aligning best practices, procedures, and applicable regulations (FDA, ISO, etc.) through cross-functional teams.
• Evaluates product changes and directs appropriate disposition of product through the company’s change control system.
• Assembles non-sterile product into kits for final release into the field.
• Participates 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 ensure receipt of quality product.
• Supports concurrent engineering efforts by participating in design development projects, representing quality assurance and the customer (supplier and end user).
• Creates and maintains 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 quality assurance issues and ensures 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 helps drive and build a Continuous Improvement and Lean culture across the organization.

Requirements

• Bachelor's degree in Engineering, Science, Technology, or a related discipline.
• 3+ years of progressive medical device engineering experience (Manufacturing, Development, or Quality Engineering) within an FDA-compliant Title 21 section 820 environment.