Medical Device Quality Engineer

About the role

Enovis is seeking a Medical Device Quality Engineer to join its Quality Assurance team in Austin, TX. The role supports quality processes, patient safety, and regulatory compliance for medical technology products.

Key responsibilities

• Ensure compliance with internal and external specifications, including GMP, ISO, FDA, and CMDR requirements.
• Support evaluation of product quality issues that may affect device performance, patient safety, or regulatory compliance.
• Assist with nonconforming material disposition through cross‑functional engineering review as part of the MRB.
• Update and maintain quality standards, procedures, and work instructions.
• Participate in process and equipment validations, including IQ, OQ, and PQ documentation.
• Support supplier quality activities such as reviewing incoming nonconformances, handling SCARs, conducting audits, and monitoring supplier performance.
• Perform trend analysis on production and quality data to identify improvement opportunities.
• Contribute to root‑cause investigations using structured problem‑solving methods.
• Assist with CAPA activities, including investigation, documentation, and effectiveness verification.
• Partner with Manufacturing and Operations to address quality or compliance concerns.

Required profile

• Foundational knowledge of engineering and problem‑solving principles.
• Ability to support quality assurance activities related to medical devices.

Required skills

• GMP compliance
• ISO standards
• FDA regulations
• CMDR requirements
• IQ/OQ/PQ documentation
• Trend analysis
• Root cause analysis
• CAPA processes
• Nonconforming material disposition
• Supplier corrective actions (SCARs)