Quality Control Manager

Quality Control Manager

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 and its culture, and to learn more about Thuasne, their rich history and the depth of products produced and sold daily around the world!

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.

• 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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