Therafirm, a Knit-Rite company and Thuasne USA are well established manufacturers of medical devices for the orthopedic, prosthetic, orthotic, diabetic and medical compression markets both in the US and worldwide. As divisions of the Thuasne Group of France, a 175-year-old family owned business, we produce products daily that help improve the quality of people’s lives all over the world. Watch these videos to learn more about

Therafirm has an immediate opening in Hamlet, NC for a Quality Control Manager in our Hamlet, North Carolina facilty!

What You’ll Get To Do

Our Quality Control Manager is responsible for overseeing the day to day operations of the Quality Lab and management of the Quality Technicians. Using Quality Engineer principles work with manufacturing managers to improve manufacturing processes and helping ensure adequate process controls to maintain or improve product quality.

The Essentials

Leads, provides direction, and manages Quality Personnel at the Hamlet facility
Manage manufacturing process and product related nonconformances (NCRs)

including raw materials, in-process products, and finished product. Review testing

reports and disposition according to specifications.

Initiate, facilitate, and manage Corrective and Preventive Actions. Includes

leading CAPA review board meetings and collaborating with Purchasing for Supplier

related Corrective Actions.

Participate in Design Transfer activities by reviewing proposed specifications,

work instructions, and other documents resulting from Research and Development. As

required, coordinate training to new documents.

Review and propose edits to existing work instructions and assist in the drafting

of new work instructions specific to the Quality lab with a focus on work instructions for

product acceptance testing.

Support Document Control and Quality and Regulatory Management in the

compliance of the Company’s Quality Management System to FDA 21CFR820, EU

Medical Device Regulation 2017/745 and latest ISO 13485 requirements, as required.

Manage the validation program for the Hamlet facility. Including working with key

stakeholders to develop validation protocols for new machinery, and management of

validations documentation.

Manage the Hamlet facilities measurement equipment calibrations, generate

supplier performance reports, and ensure the Quality Technicians are trained per the

established training plans for the department as applicable.

Generate scrap reports and email to appropriate stakeholders, Review scrap

reports for trends or recuring issues as needed. Update the Hamlet Production Report

and monthly productivity report with required scrap and Quality Lab performance data.

Active member and participant in the Company’s Process Improvement Program
Actively participate in Hamlet Managers meetings and the Hamlet Production

meetings, along with taking an active leadership role within the Hamlet facility.

Other duties and projects as assigned

What You’ll Bring

Engineering/Technical/Business Associates required or Bachelor’s degree preferred
Minimum of 3 years’ experience in a quality function or combination of experience & education
Previous experience as a Manager, Supervisor, or Team Lead
Lean Manufacturing certifications preferred, but not required
Proficient in the use of a wide variety of computer applications

What We Offer

Competitive Compensation package
Excellent Annual Bonus Opportunity
Competitive Benefits that include medical, dental, & vision insurances
401K with company match
Convenient Location
Family Atmosphere
Paid Time Off Program
Volunteer Program
Educational Assistance
Employee Referral Program

If you are detailed, driven, and passionate about helping make a difference, this is the job for you!

Equal Opportunity Employer: Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, veteran’s status, age or disability.

Drug-free work environment

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Quality Control Manager