What are the responsibilities and job description for the Quality Assurance Specialist position at Kelly Science, Engineering, Technology & Telecom?
Job Description
We are seeking a highly skilled Quality Assurance Specialist to join our team at Kelly Science, Engineering, Technology & Telecom.
The successful candidate will be responsible for ensuring metrology and inspection control at the manufacturing site are implemented, maintained and improved continuously. This includes defining and maintaining metrology and calibration strategies, driving improvements to enhance metrology and calibration, creating/updating procedures for metrology and calibration and ensuring adherence to these procedures.
The ideal candidate will have a solid knowledge of regulatory requirements related to calibration and metrology, ISO 13485 (Quality Management System for Medical Devices) and a minimum Bachelor's degree in a relevant scientific discipline. Additionally, they should have expertise in statistical data analysis and at least 2 years of experience in the field of calibration or metrology in the medical device or pharmaceutical industry.
The selected candidate will be able to drive improvement projects simultaneously, implement test method validation procedures that describe processes adequately and are regulatory compliant as well as efficient use of resources. They should also be able to assess the impact of manufacturing changes on calibration and metrology and author, revise and review technical and procedural documentation related to calibration and metrology practices.
Key responsibilities include:
- Define and maintain metrology and calibration strategies
- Drive improvements to enhance metrology and calibration
- Create/update procedures for metrology and calibration and ensure adherence
- Evaluate compliance with Quality Regulations, ISO, AAMI standards and regional requirements
Critical success factors include:
- Able to drive improvement projects simultaneously
- Able to implement test method validation procedures efficiently
- Able to assess the impact of manufacturing changes on calibration and metrology
If you are a motivated and experienced professional looking for a new challenge, please submit your application. We look forward to hearing from you.
