The Quality Control Specialist will provide support in CAPA, complaints, validations, audits, quality holds, maintenance and calibration, product testing and various other requirements in support of Business Development, Process Engineering, Manufacturing, Quality, and Regulatory within the constraints of domestic and foreign Medical Device Regulations.
- Support manufacturing to ensure compliance to all applicable requirements and standards
- Perform complaint investigations, NCMRs and provide support of CAPAs
- Participate in the development and/or revision of DMRs
- Reviews device history records and manufacturing records to verify the information is accurate and complete and that all specifications have been met.
- Work with suppliers/customers for resolution of complaint investigations
- Perform First Article inspection and incoming material inspection
- Perform general receiving inspection, in-process and final inspection of product, packaging and labeling
- Ensures measurement, test and inspection equipment is calibrated and in good condition
- Assist in the development and testing of new or revised products, equipment and procedures
- Managing and maintaining maintenance and calibration schedules
- Assist as needed with the Internal Audit Program
- Perform other duties as assigned
- Associate degree or higher in Technology, Engineering or equivalent
- 1-2 years of experience in biotechnology or FDA regulated industry
- Strong analytical skills and attention to detail
- Excellent written and verbal communication skills
Sthree US is acting as an Employment Business in relation to this vacancy.