Senior Manager, Quality Assurance

DJO Tunisie; Fort Worth (TX); Vor Ort; USD 140.000 - 200.000; Vollzeit

Benefits dieser Stelle

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Vacation, Sick Leave, Holidays

Zusammenfassung

Enovis Fort Worth, TX, seeks a Sr. Manager of Quality Assurance to lead a team of quality engineers and technicians, ensuring regulatory compliance and robust process controls across the Recovery Sciences device portfolio.

You will drive CAPA, support audits, and collaborate with Manufacturing, R&D, and Supply Chain to enhance product reliability and operational efficiency. Strong leadership and regulatory knowledge are essential.

Qualifikationen

• Bachelor's degree in Engineering; 8+ years in quality engineering in medical devices.
• 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.

Aufgaben

• 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, 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 Laser safety officer for the DFW location.
• Represent the LiteCure Quality Management System as Management Representative.

Kenntnisse

Quality engineering

Leadership

Regulatory compliance

Risk management

Communication

Ausbildung

Bachelor's degree in Engineering

Master's degree preferred

Tools

eQMS

Statistical software

Metrology tools

Jobbeschreibung

Who We Are

ABOUT ENOVIS™

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 Enovis™ 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, 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.

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 Services

"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

Join 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,