Senior Manager, Quality Assurance

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

Senior Manager, Quality AssuranceThis site uses cookies and other tracking technologies to provide you with our services, enhance the performance and functionality of our services, analyze the use of our products and services, and assist with our advertising and marketing efforts. To view the cookie policy, please click **here**.### Senior Manager, Quality AssuranceApply: USA, Texas, Fort Worth: Full time: Posted Yesterday: R0034695## **Who We Are****ABOUT ENOVISTM**Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com.**What You'll Do**At EnovisTM we pay attention to the details. We embrace collaboration with our partners and patients, and take pride in the pursuit of scientific excellence — with the goal of transforming medical technology as we know it. Because that’s how we change the lives of patients for the better. And that’s how we create better together. Why work at Enovis? See for yourself. As a key member of the Quality Assurance team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.**Job Title**:Sr Manager, Quality Assurance**Reports To**:Director, Quality Assurance**Location:**Fort Worth, TX**Business Unit Description**:QA**Job Title/High-Level Position Summary:**The Sr. Quality Assurance Manager is responsible for leading a team of quality engineers and Quality technicians in driving product and process excellence across the Recovery Sciences device portfolio. This role ensures compliance with regulatory standards, support manufacturing as well as new product introduction and fosters a culture of continuous improvement. The Sr. Quality Assurance Manager will collaborate cross-functionally to implement quality strategies that enhance product reliability, reduce risk, and improve operational efficiency across multiple locations.**Key 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.**Minimum Qualifications*** Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, or related field); Master’s degree preferred.* 8+ years of experience in quality engineering within medical devices or other 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.**Desired Characteristics:*** ASQ Certified Quality Engineer (CQE) or 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.*Currently, Enovis does not provide sponsorship for employment visas (e.g., H-1B) and will not offer such sponsorship in the future. Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.* **“Creating better together”. It’s the Enovis purpose, and it’s what drives us and empowers us every day on a global scale.** We know that the power to create better – for our customers, our team members, and our shareholders – begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.**What does creating better together mean to us at Enovis? Discover the “why” behind our purpose, values and behaviors:**Our Enovis Purpose, Values and Behaviors on Vimeo We offer a comprehensive benefits package that includes:* Medical Insurance* Dental Insurance* Vision Insurance* Spending and Savings Accounts* 401(k) Plan* Vacation, Sick Leave, and Holidays* Income Protection Plans* Discounted Insurance Rates* Legal ServicesJoin us in creating better together.**EQUAL EMPLOYMENT OPPORTUNITY** Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees’ beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.