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 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

Knit-Rite, LLC and affiliates participate in E-Verify

• NO AGENCIES PLEASE** Any Employment Agency, person or entity that submits an unsolicited resume to this site does so with the understanding that the applicant's resume will become the property of Knit-Rite, LLC and its affiliates. Knit-Rite, LLC and affiliates will have the right to hire that applicant at its discretion and without any fee owed to the submitting Employment Agency, person or entity.
  
  

Powered by JazzHR

wwamySUbPm