Medical Device Quality Engineer — Supplier & Compliance

enovis; Austin (TX); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Spending and Savings Accounts

401(k) Plan

Vacation, Sick Leave, and Holidays

Income Protection Plans

Discounted Insurance Rates

Legal Services

Job summary

Enovis in Austin, TX is seeking a Medical Device Quality Engineer to join the Quality Assurance team in ensuring patient safety and regulatory compliance.

You will evaluate nonconforming material, lead root-cause analyses, and support manufacturing transfers and validations (IQ/OQ/PQ). This office-based role requires strong communication and solid knowledge of GMP, ISO, and FDA guidelines.

Qualifications

• Bachelor’s in Science or Engineering with 3–5 years of experience.
• Experience with manufacturing transfers and IQ/OQ/PQ validation in a regulated environment.
• Background in Medical Device or other highly regulated industries; ISO 13485 knowledge preferred.
• Strong technical writing ability and documentation practices.
• Familiarity with manufacturing processes such as metrology, machining, cleaning, and sterilization.
• Proficiency with Microsoft Office suite.
• Preferred CQE, Lean, or 6 Sigma certifications.

Responsibilities

• Evaluate nonconforming material and dispositioning based on cross-functional review.
• Analyze reports and production data to identify trends.
• Update or change quality standards and procedures as needed.
• Author/process and equipment validation documentation.
• Ensure compliance to GMP, ISO, FDA, CMDR standards.
• Review device failure trends related to customer complaints.
• Lead root cause analysis and CAPA investigations.
• Support manufacturing to address quality or compliance issues.
• Work on complex special projects as assigned.

Skills

Manufacturing transfers

IQ/OQ/PQ validation

Technical writing

MS Office

Regulated industry know-how

Quality systems

English communication

Education

Bachelor’s in Science or Engineering

Tools

Solidworks

Solidworks ePDM

Oracle R12

Agile PLM

Job description

Enovis in Austin, TX is seeking a Medical Device Quality Engineer to join the Quality Assurance team in ensuring patient safety and regulatory compliance.

You will evaluate nonconforming material, lead root-cause analyses, and support manufacturing transfers and validations (IQ/OQ/PQ). This office-based role requires strong communication and solid knowledge of GMP, ISO, and FDA guidelines.