Quality Control Manager
Knit Rite/Thuasne USA
- Hamlet, NC
- Permanent
- Full-time
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
- 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