Associate Manager, Quality Engineering

ABOUT ENOVIS™ Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit

As a key member of the Quality Assurance Team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.

Job Title:

Associate Manager, Quality Engineering

Reports To:

Associate Director, Quality Engineering

Location:

Austin, Texas Business Unit

Description:

Quality Assurance

• Provide day-to-day technical guidance, direction, and support to Quality Engineers and other Quality team members.
• Assist in managing team priorities, resource allocation, employee development, and execution of departmental objectives to ensure business and quality goals are achieved.
• Manage and supervise assigned Quality Engineering personnel, including performance management, coaching, training, development planning, and employee engagement activities.
• Coach and develop team members through regular feedback, technical guidance, and development opportunities.
• Serve as a key Quality partner to Manufacturing and Operations, providing timely support for production and quality-related issues.
• Lead and facilitate risk-based decision making regarding manufacturing deviations, process changes, supplier-related quality issues, and product quality concerns.
• Lead and support Material Review Board (MRB) activities, including evaluation and disposition of nonconforming material.
• Monitor production and quality data, communicate key metrics, identify emerging risks and trends, and elevate significant quality concerns as appropriate.
• Lead root cause and CAPA investigations using structured problem-solving methodologies and ensure corrective actions are implemented and verified for effectiveness.
• Lead or support process and equipment validations, including IQ/OQ/PQ/TMV, and review and approve related protocols, reports, and engineering documentation.
• Lead or support supplier quality activities including supplier investigations, Supplier Corrective Action Requests (SCARs), supplier performance monitoring, supplier transfers, and supplier change management activities.
• Develop and recommend updates to quality standards, procedures, work instructions, and processes.
• Monitor and drive site quality metrics including FPY, NCMRs, CAPA effectiveness, complaint trends, and audit performance.
• Develop action plans to address adverse trends.
• Support compliance with applicable internal requirements and regulatory standards, including GMP, FDA requirements, and ISO 13485.
• Review trends related to scrap, nonconforming material, process deviations, and device failures to identify systemic quality concerns.
• Partner cross-functionally with Manufacturing, Engineering, and Operations to resolve quality issues and support manufacturing transfers, new product introductions, process changes, and continuous improvement initiatives.
• Participate in internal, external, and regulatory audits and support timely resolution of audit observations.
• Promote a culture of quality, accountability, collaboration, and continuous improvement, and lead complex projects and quality initiatives as assigned.

• Bachelor's degree in Engineering, Science, or a related technical discipline required.
• 5+ years of Quality Engineering, Manufacturing Engineering, or related experience within a regulated manufacturing environment.
• Experience with in Medical Device, Aerospace, Automotive, or another highly regulated manufacturing industry required; medical device manufacturing experience strongly preferred.
• Previous experience leading projects, mentoring employees, serving as a technical lead, or providing day-to-day direction to a team.
• Experience with manufacturing transfers and process/equipment validation, including IQ/OQ/PQ, required.
• Demonstrated experience with root cause analysis, CAPA, nonconforming material, and structured problem-solving methodologies.
• Strong technical writing skills with demonstrated ability to develop, review, and approve quality documentation.
• Working…