Senior Quality Assurance Manager — Medical Devices

Enovis Corporation; Fort Worth (TX); On-site; USD 130,000 - 180,000; 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 Corporation in Fort Worth, TX, is seeking a Sr Manager, Quality Assurance to lead a team of quality engineers and technicians, drive product/process excellence, and ensure regulatory compliance across the Recovery Sciences device portfolio.

This role partners with Manufacturing, R&D, Regulatory Affairs, and Supply Chain to implement quality strategies that improve reliability, reduce risk, and enhance operational efficiency across locations.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, or related field); Master’s degree preferred.
• 8+ years of experience in quality engineering in medical devices or regulated industries, including 3+ years in a leadership role.
• Strong knowledge of ISO 13485, FDA QSR, ISO 14971.
• Proven ability to lead cross-functional teams and manage complex projects.
• Excellent communication, analytical, and problem-solving skills.

Responsibilities

• Lead and mentor a team of quality engineers and technicians, providing technical guidance and performance management.
• Develop and implement quality strategies that align with business objectives and regulatory requirements.
• Lead quality engineering support for manufacturing operations, ensuring robust process controls, effective risk management, and validation of production methods.
• Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971 standards.
• Drive root cause analysis and corrective/preventive actions (CAPA) for product and process issues.
• Collaborate with Manufacturing, R&D, Regulatory Affairs, and Supply Chain to resolve quality challenges and improve processes.
• Support internal and external audits, acting as a subject matter expert for quality engineering practices.
• Maintain and improve quality system documentation, including procedures, work instructions, and validation protocols.
• Be qualified as a Lazer safety officer for the DFW location.
• Represent the LiteCure Quality Management System as Management Representative.

Skills

Cross-functional leadership

Communication skills

Analytical skills

Problem-solving

Education

Bachelor's degree in Engineering

Master’s degree preferred

Tools

eQMS systems

Statistical software

Metrology tools

Job description

Enovis Corporation in Fort Worth, TX, is seeking a Sr Manager, Quality Assurance to lead a team of quality engineers and technicians, drive product/process excellence, and ensure regulatory compliance across the Recovery Sciences device portfolio.

This role partners with Manufacturing, R&D, Regulatory Affairs, and Supply Chain to implement quality strategies that improve reliability, reduce risk, and enhance operational efficiency across locations.