Senior Quality Engineer, Enabling Technology

Enovis; Austin (TX); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Vacation, Sick Leave, Holidays

Income Protection Plans

Discounted Insurance Rates

Job summary

Enovis in Austin, TX seeks a Sr. Quality Engineer to provide technical leadership across new product development and sustaining programs.

You will ensure product and process compliance with internal quality systems, global regulatory requirements, and industry standards while partnering with cross-functional teams to drive product quality, regulatory compliance, and continuous improvement throughout the product lifecycle.

Qualifications

• Bachelor's degree in Biomedical, Mechanical, Manufacturing or related technical discipline.
• Experience with FDA QSR 21 CFR Part 820, ISO 13485, ISO 14971 and similar regulations.
• Experience supporting new product development using Design Controls and risk management.

Responsibilities

• Serve as senior QA representative for NPD and sustaining engineering projects.
• Lead design and manufacturing reviews to ensure QMS compliance and regulatory alignment.
• Lead risk management activities including DFMEA, PFMEA, and risk docs per ISO 14971.
• Review and approve design control documentation including inputs/outputs, V&V protocols and changes.
• Provide technical leadership during audits (FDA, ISO 13485, MDSAP).
• Lead CAPA investigations, root cause analyses and verification activities.
• Drive Lean, Six Sigma, and quality engineering improvements.
• Mentor junior QA engineers and cross-functional teams.

Skills

Leadership

Regulatory compliance

Analytical thinking

Problem-solving

Written communication

Cross-functional collaboration

Project management

Attention to detail

Mentoring

Education

Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or related technical discipline

Tools

Agile PLM

Oracle

SAP

Windchill

Job description

Enovis in Austin, TX seeks a Sr. Quality Engineer to provide technical leadership across new product development and sustaining programs.

You will ensure product and process compliance with internal quality systems, global regulatory requirements, and industry standards while partnering with cross-functional teams to drive product quality, regulatory compliance, and continuous improvement throughout the product lifecycle.