Senior Quality Engineer – Enabling Tech (Medical Devices)

Enovis Corporation; Austin (TX); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Spending and Savings Accounts

401(k) Plan

Vacation, Sick Leave, Holidays

Income Protection Plans

Discounted Insurance Rates

Legal Services

Job summary

Enovis Corporation in Austin, TX seeks a Sr. Quality Engineer to provide technical leadership across new product development and sustaining engineering. You will ensure compliance with QMS, FDA/ISO requirements and drive quality improvements throughout the product lifecycle.

You will lead design reviews, risk management, and validation activities, mentor junior engineers, and support audits and supplier quality initiatives in a fast-paced medical device environment.

Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or related technical discipline.
• 3+ years of Quality Assurance experience within the medical device industry or another highly regulated industry.
• Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971, and applicable international regulations.
• Demonstrated experience supporting new product development using Design Controls.
• Experience leading CAPA investigations, internal audits, risk management activities, and quality system improvements.
• Strong understanding of manufacturing processes, process validation, and statistical analysis techniques.
• Excellent technical writing, analytical, and problem-solving skills.
• Strong communication and leadership skills with the ability to influence cross-functional teams.

Responsibilities

• Serve as the senior QA representative for new product development projects.
• Lead design and manufacturing reviews to ensure QMS and regulatory compliance.
• Lead risk management activities, including DFMEAs, PFMEAs, and ISO 14971.
• Review and approve design control documentation and test protocols.
• Provide leadership during audits (FDA, ISO 13485, MDSAP).
• Lead CAPA investigations, root cause analyses, and verification activities.
• Drive continuous improvement using Lean, Six Sigma, and quality engineering principles.
• Mentor junior QA Engineers and cross-functional teams.

Skills

Quality Assurance

Regulatory compliance

FDA 21 CFR 820

ISO 13485

CAPA investigations

Risk management

V&V strategies

Software in medical devices

Education

Bachelor's degree in Biomedical Engineering/Mechanical/Manufacturing

Job description

Enovis Corporation in Austin, TX seeks a Sr. Quality Engineer to provide technical leadership across new product development and sustaining engineering. You will ensure compliance with QMS, FDA/ISO requirements and drive quality improvements throughout the product lifecycle.

You will lead design reviews, risk management, and validation activities, mentor junior engineers, and support audits and supplier quality initiatives in a fast-paced medical device environment.