Senior Quality Assurance Leader, Medical Devices

DJO, LLC; Fort Worth (TX); On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Vacation

Sick Leave

Holidays

Income Protection

Discounted Insurance Rates

Legal Services

Job summary

Enovis, Fort Worth, TX, seeks a Sr Manager of Quality Assurance to lead a team of quality engineers and technicians, ensuring compliance with regulatory standards and driving product/process excellence across the Recovery Sciences device portfolio.

The role focuses on implementing quality strategies, supporting manufacturing operations, and guiding CAPA activities while collaborating with multiple functions to improve reliability and reduce risk.

Qualifications

• Bachelor's degree in Engineering required or equivalent.
• 8+ years of quality engineering experience in medical devices or regulated industries.
• 3+ years in a leadership role.
• Strong knowledge of ISO 13485, FDA QSR, ISO 14971.

Responsibilities

• Lead and mentor a team of quality engineers and technicians.
• Develop and implement quality strategies aligned with regulatory requirements.
• Provide quality engineering support for manufacturing operations and new product introductions.
• Support audits and maintain quality system documentation.

Skills

Leadership

Cross-functional leadership

Quality engineering

Regulatory knowledge

CAPA

Risk management

QMS documentation

Audit support

Education

Bachelor's in Engineering

Master's degree preferred

Tools

eQMS

Statistical software

Metrology tools

Job description

Enovis, Fort Worth, TX, seeks a Sr Manager of Quality Assurance to lead a team of quality engineers and technicians, ensuring compliance with regulatory standards and driving product/process excellence across the Recovery Sciences device portfolio.

The role focuses on implementing quality strategies, supporting manufacturing operations, and guiding CAPA activities while collaborating with multiple functions to improve reliability and reduce risk.