Senior QA Manager: Medical Devices & Regulatory

Enovis; Fort Worth (TX); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Vacation, Sick Leave, and Holidays

Income Protection Plans

Discounted Insurance Rates

Legal Services

Job summary

Enovis is seeking a Sr Manager, Quality Assurance in Fort Worth, TX. The role leads a team of quality engineers and technicians, driving product and process excellence while ensuring regulatory compliance and alignment with manufacturing and new product introductions.

The position focuses on implementing quality strategies, reducing risk, and improving operational efficiency across multiple sites. Strong leadership and communication are essential to drive CAPA and audits.

Qualifications

• Bachelor’s degree in Engineering or related field required.
• 8+ years in quality engineering within medical devices or regulated industries.
• At least 3+ years in a leadership role.
• Strong knowledge of ISO 13485, FDA QSR, ISO 14971.

Responsibilities

• Lead a team of quality engineers and technicians; provide coaching and performance management.
• Develop and implement quality strategies aligned with regulatory requirements.
• Oversee quality engineering support for manufacturing; ensure robust process controls and CAPA.
• Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971.

Skills

Leadership

Quality engineering

Regulatory compliance

Cross-functional teams

Problem solving

Education

Bachelor’s degree in Engineering

Master’s degree preferred

Tools

eQMS

Statistical software

Metrology tools

Job description

Enovis is seeking a Sr Manager, Quality Assurance in Fort Worth, TX. The role leads a team of quality engineers and technicians, driving product and process excellence while ensuring regulatory compliance and alignment with manufacturing and new product introductions.

The position focuses on implementing quality strategies, reducing risk, and improving operational efficiency across multiple sites. Strong leadership and communication are essential to drive CAPA and audits.