Associate Manager, Quality Engineering The Associate Manager, Quality Engineering provides day-to-day leadership, technical guidance and support to the Quality Engineering team while remaining actively involved in supporting manufacturing operations. This role serves as a key quality partner to Manufacturing and Operations, supporting and leading quality investigations, Material Review Board (MRB) activities, continuous improvement initiatives, and quality system compliance. The Associate Manager also supports the leader of quality with team priorities, employee development, and execution of departmental objectives.
Key Responsibilities:
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 escalate 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.
Minimum Basic Qualifications:- 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 within 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 knowledge of manufacturing processes with emphasis on areas such as metrology, precision machining, grinding, product cleaning, and sterilization.
- Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.
- Desired Characteristics:
- Working knowledge of FDA Quality System requirements, GMP, and ISO 13485 standards preferred.
- CQE, CQA, Lean, Six Sigma, or similar quality certification preferred.
- Demonstrated ability to provide guidance, coach, and develop employees while maintaining strong collaborative relationships.
- Ability to balance technical responsibilities, team support, and changing operational priorities.
- Strong judgment with the ability to identify and appropriately escalate significant quality, compliance, or business risks.
- Ability to influence and collaborate effectively across functions and organizational levels.
- Strong analytical and problem-solving skills with the ability to make sound, data-driven decisions.
- Excellent written and verbal communication skills, including the ability to communicate complex technical issues to both technical and non-technical audiences.
- Strong organizational skills and ability to manage multiple priorities in a fast-paced manufacturing environment.
- Demonstrated commitment to quality, accountability, customer service, and continuous improvement.
- Professional judgment, ethics, and demeanor.
- Position is office/manufacturing-site based in Austin, Texas.
- Must be able to lift up to 50 lbs.
- Must be able to bend, twist, and lift overhead.
- Must be able to communicate clearly and fluently in English, both verbally and in writing.
- Currently, Enovis does not provide sponsorship for employment visas (e.g., H-1B) and will not offer such sponsorship in the future. Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.
