Senior Quality Engineer — Lead QA & Compliance, MedTech

Enovis Healthcare Solutions; Austin (TX); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Vacation/Sick/Holidays

Job summary

Enovis seeks a Sr. Quality Engineer to provide technical leadership across new product development and sustaining engineering programs.

You will ensure products and processes comply with internal quality systems and global regulatory requirements while partnering with cross-functional teams to drive product quality and continuous improvement. You will also lead audits (FDA/ISO/MDSAP), manage risk, and guide CAPA investigations, with a focus on design controls and software as a medical device.

Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or related technical discipline.
• 3+ years of Quality Assurance experience within medical device or highly regulated industries.
• Strong knowledge of FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, and applicable regulations.
• Experience leading CAPA investigations, internal audits, risk management activities, and QA improvements.
• Strong understanding of manufacturing processes, process validation, and statistical analysis techniques.
• Excellent technical writing, analytical, and problem-solving skills.
• Strong communication and leadership with cross-functional influence.
• Knowledge and experience with software as a medical device.
• Independently plan, develop, and execute software verification/validation (V&V) strategies aligned with regulatory requirements.
• Review/approve software requirements, design docs, risk management files, and test protocols for traceability and compliance.
• Review/approve detailed test protocols and evidence of test execution per procedures.

Responsibilities

• Serve as senior QA representative for NPD and sustaining projects.
• Lead design/manufacturing reviews to ensure QMS and regulatory compliance.
• Lead risk management activities (DFMEAs/PFMEAs) per ISO 14971.
• Review/approve design control documentation and change controls.
• Provide QA leadership during audits (FDA, ISO 13485, MDSAP).
• Lead CAPA investigations and root cause analyses with verification.
• Drive continuous improvement using Lean/Six Sigma principles.
• Mentor junior QA engineers and cross-functional teams.
• Analyze quality metrics and manufacturing data to identify systemic risks and corrective actions.
• Collaborate with Engineering, Regulatory, Manufacturing, and Ops to ensure product quality.
• Develop, review, maintain quality procedures, work instructions, and validation docs.
• Support supplier quality activities and process validation as required.

Skills

Quality Assurance

Regulatory Compliance

Design Controls

Risk Management

CAPA

Audits

Statistical Analysis

Lean Six Sigma

Software as a Medical Device

V&V Planning

Education

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

Tools

FDA 21 CFR 820

ISO 13485

ISO 14971

Agile PLM

Oracle SAP Windchill

Statistical Software

Job description

Enovis seeks a Sr. Quality Engineer to provide technical leadership across new product development and sustaining engineering programs.

You will ensure products and processes comply with internal quality systems and global regulatory requirements while partnering with cross-functional teams to drive product quality and continuous improvement. You will also lead audits (FDA/ISO/MDSAP), manage risk, and guide CAPA investigations, with a focus on design controls and software as a medical device.