Headquartered in Spartanburg, South Carolina, Milliken & Company is a global, innovative, industrial diversified manufacturing company that has been exploring, discovering, and creating ways to enhance people's lives since 1865. With expertise across a breadth of disciplines including specialty chemical, floor covering, and performance materials, the company works around the world every day to add true value to people's lives, improve health and safety, and help make our world more sustainable. Milliken has long led the way for \\"knowledge-based\\" investment, employing over 100 PhDs, and has accumulated over 2,200 U.S. patents - and more than 5,000 patents worldwide. Milliken is widely acknowledged as an international leader in research technology, innovation, and customer service. With over 35 manufacturing facilities located in the U.S., U.K., Belgium, France, China, India, Mexico, and Australia, and other sales and service operations throughout the Americas, Europe and Asia, Milliken's more than 7,000 associates work to deliver innovations that do good for the world, create new experiences, and build for the future.
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Job Description: In this role, the individual will interact with all functional areas of Milliken Healthcare Products, LLC. The individual assists with the daily management and maintenance of a medical device quality system. The position reports to the Quality Assurance/Regulatory Affairs Manager. The associate will perform or assist in the following key responsibilities and key duties as well as other duties as requested:

Key Responsibilities
- Assist with the implementation and maintenance of a Quality System based on ISO 13485 and FDA Quality System Regulation (QSR)
- Document Control - Responsible for control of documentation required for the Quality System
- SPI System Owner - Responsible for Standard Operating Procedures
- Training - Ensure associate training is completed according to schedule and assist in development of the training program
- Corrective and Preventive Action (CAPA) - Monitor status of CAPAs to ensure they are completed as quickly and completely as possible

Key Duties/Tasks
- Identify quality issues as they arise and communicate to management
- Maintain quality system procedures (SPIs) and ensure all necessary documents are properly controlled
- Assist in development and maintenance of an effective quality system training program for all appropriate business associates
- Maintain an effective Corrective and Preventive Action (CAPA) system
- Assist RA/QA manager with preparation and execution of Management Reviews on a regular basis
- Ensure an effective supplier quality assurance system while ensuring supplier corrective actions are timely and effective
- Implement new inspection, measurement and testing systems for quality monitoring and improvement
- Track and report significant quality deviations
- Assist with quality inspection and product release programs throughout all stages of production
- Participate in engineering activities to ensure proper quality assurance and control plans can be implemented prior to beginning manufacturing
- Participate in audit activities including internal, external, supplier, and FDA audits
- Write and/or review protocols and reports for various quality system and regulatory activities
- Perform laboratory or in process quality testing on devices or components to verify their compliance

Requirements
- Associate's Degree required; Bachelor's Degree preferred
- 2+ years combined regulatory and/or quality experience; Preference given to regulatory experience
- Medical device industry experience preferred
- Experience in and comfortability with MS Office suite (Excel, PowerPoint, Word)
- Experience in an electronic quality management system preferred

Milliken & Company is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with a disability..