Associate Manager, Quality Engineering

About the role

Enovis is seeking an Associate Manager, Quality Engineering to lead and support its Quality Engineering team in Austin, Texas. The role provides day‑to‑day technical guidance, partners with manufacturing, and drives quality system compliance.

Key responsibilities

• Provide technical direction and support to Quality Engineers and other team members.
• Manage team priorities, resource allocation, employee development, and departmental objectives.
• Lead risk‑based decision making for manufacturing deviations, process changes, and supplier quality issues.
• Facilitate Material Review Board activities and disposition of non‑conforming material.
• Monitor production and quality data, identify emerging risks, and communicate key metrics.
• Lead root cause and CAPA investigations using structured problem‑solving methods.
• Support process and equipment validations (IQ/OQ/PQ/TMV) and approve related documentation.
• Drive supplier quality activities, including investigations, SCARs, and performance monitoring.
• Develop and update quality standards, procedures, and work instructions.
• Ensure compliance with GMP, FDA requirements, and ISO 13485.

Required profile

• Bachelor’s degree in Engineering, Science, or a related technical discipline.
• Minimum 5 years of Quality or Manufacturing Engineering experience in a regulated environment, preferably medical devices.
• Experience leading projects, mentoring staff, and managing day‑to‑day team direction.
• Hands‑on experience with manufacturing transfers and process/equipment validation (IQ/OQ/PQ).
• Strong technical writing ability for quality documentation.

Required skills

• Proficiency with Microsoft Office applications (Excel, Word, PowerPoint).
• Knowledge of FDA Quality System requirements, GMP, and ISO 13485.
• Experience with root cause analysis, CAPA, and structured problem‑solving methodologies.
• Familiarity with validation protocols (IQ/OQ/PQ) and equipment qualification.
• Certifications such as CQE, CQA, Lean, Six Sigma are preferred.