Manager, Quality Assurance

Posted 10 Days Ago
Be an Early Applicant
Fort Worth, TX
Senior level
Healthtech
The Role
The Quality Assurance Manager oversees QA activities, ensures compliance with standards, conducts audits, and manages a small QA team in the medical device sector.
Summary Generated by Built In

Job Description:

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 Distribution Center, 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:
Manager, Quality Assurance

Reports To:
Director, Quality Assurance-Recovery Sciences

Location:
3300 Eagle Pkwy, Suite 150 Ft. Worth, TX 76177

Business Unit Description:
QA - LiteCure

Job Title/High-Level Position Summary:

The Quality Assurance Manager is responsible for managing, developing, implementing, and maintaining technical systems and activities for a small Quality Assurance and/or Quality Control group.

Key Responsibilities:

  • Defines and specifies the implementation of standards, methods, and procedures for inspecting, testing and evaluating the quality, precision, accuracy and reliability of company products.
  • Ensures compliance with Company standards and government regulations.
  • Participates in the reviewing and assessing of engineering designs.
  • Assists product support areas in gathering and analyzing data.
  • Responsible for monitoring and reporting on product quality, performance and reporting on this through management review.
  • Candidate must have a strong understanding /knowledge of FDA device requirements, ISO 13485, MDSAP and will be required to represent the business in audits of these areas.
  • It is essential that they have a solid understanding of root cause analysis, CAPA and none-conforming product management.
  • Has typically authority of a manager including hiring, disciplining, and terminating.
  • Has budgetary responsibility.  

Minimum Qualifications:

  • 8+ Yrs of Work Exp in QA with a specific focus on Medical Devices
  • BS/BA

Desired Characteristics:

  • 5+ yrs of mgmt. exp
  • Lean or 6 Sigma Certification

“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 Services
     

Join us in creating better together.

#LI-RC2

                                                                                                     

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.

EOE AA M/F/VET/Disability Statement

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.

Top Skills

Fda Device Requirements
Iso 13485
Lean
Six Sigma
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The Company
HQ: Wilmington, DE
1,217 Employees
On-site Workplace
Year Founded: 2022

What We Do

We are a medical technology company focused on developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows.

Powered by a culture of continuous improvement, extraordinary talent and innovation, we ‘create better together’ by partnering with healthcare professionals. Our extensive range of products, services and integrated technologies fuel active lifestyles.

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