Senior Manager, Quality Assurance

Enovis•Fort Worth, TX

6d•Onsite

About The Position

The Senior Manager, Quality Assurance leads a team of quality engineers and technicians to drive product and process excellence across the Recovery Sciences device portfolio. The role ensures regulatory compliance, supports manufacturing and new product introduction, and fosters continuous improvement. It collaborates across functions and locations to improve product reliability, reduce risk, and increase operational efficiency. The position is based in Fort Worth, Texas, and reports to the Director, Quality Assurance. The manager also serves as the Management Representative for the LiteCure Quality Management System and must qualify as a laser safety officer for the DFW location.

Requirements

Bachelor’s degree in Engineering, such as Mechanical, Biomedical, Industrial, or a related field.
At least 8 years of quality engineering experience in medical devices or other regulated industries, including at least 3 years in a leadership role.
Strong knowledge of ISO 13485, FDA QSR, and ISO 14971.
Ability to lead cross-functional teams and manage complex projects.
Excellent communication, analytical, and problem-solving skills.
Must already have full-time work authorization in the United States and be able to maintain it without employment visa sponsorship.

Nice To Haves

Master’s degree.
ASQ Certified Quality Engineer (CQE), Certified Quality Manager (CQM), Certified Quality Auditor (CQA), or Six Sigma Black Belt.
Familiarity with eQMS systems, statistical software, and metrology tools.
Demonstrated success in driving quality improvements and regulatory compliance.

Responsibilities

Lead and mentor quality engineers and technicians, providing technical guidance and performance management.
Develop and implement quality strategies aligned with business objectives and regulatory requirements.
Provide quality engineering support for manufacturing operations, including process controls, risk management, and validation of production methods.
Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971.
Lead root cause analysis and corrective and 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 as a subject matter expert in quality engineering practices.
Maintain and improve quality system documentation, including procedures, work instructions, and validation protocols.
Qualify as a laser safety officer for the DFW location.
Represent the LiteCure Quality Management System as Management Representative.