Quality Engineer

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.

POSITION SUMMARY:

The Quality Engineer (QE) will be responsible for management and execution of assigned quality projects in order to meet quality assurance objectives.  This position will work cross functionally to support and enhance quality processes, ensuring compliance with regulatory requirements, quality standards and internal procedures.

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
• 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 product and 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
• Supports product transfer activities to current and new suppliers
• Participate in hands on cadaver labs
• Participates in projects and supports actions initiated in the Continuous Improvement program
• Participates in project Kaizens, Rapid Improvement Events, and build a Continuous Improvement and Lean culture across the organization

EDUCATION & EXPERIENCE REQUIREMENTS:

• Bachelor's degree in Engineering, Science, Technology or a related field required.
• 3+ years of progressive medical device engineering experience (Manufacturing, Development or Quality Engineering) within an FDA-compliant Title 21 section 820 environment
• Preferred experience with virtual surgical planning or custom medical devices
• Ability to travel ~10-30% of the time for vendor visits, audits, process troubleshooting, etc.

All your information will be kept confidential according to EEO guidelines.

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