Regulatory/Quality Affairs Coordinator
Position Description: Regulatory/Quality Affairs Coordinator - reports to company’s Manager of Quality Assurance and Regulatory Affairs.
Position Location: Arden, North Carolina company headquarters. Company designs, manufactures, and markets class 2 surgical apparel and accessory devices. Compensation in $40,000 plus range commensurate with relevant experience.
Primary Function: Assist Manager of QA/RA in monitoring and maintaining compliance with company quality system with an emphasis with respect to the US FDA medical device requirements. Administrative function to include responsibility over corporate QA/RA documents, employee training, and internal audits.
Duties and Responsibilities:
- Assist Product Development teams in design control compliance per the FDA QSR, including control of materials and components used in finished devices
- Coordinate and maintain Corporate QA/RA documentation files, including corrective and preventive action (CAPA) compliance per FDA QSR
-Coordinate and manage customer complaint handling function
-Perform internal audits to ensure compliance with company quality system
- Perform supplier qualifications and internal audits
Background and Experience: Three or more years in a similar position with FDA QSR experience at class 2 device manufacturer. Strong administrative, written, and oral skills. Spanish bilingual a plus. Computer literacy in Word, Power Point, and Excel or trainable in. BS degree a plus but not required if candidate has the requisite training and experience.
Interested parties send resumes to ljohnson@preceptmed.com