Description:
The successful candidate will be part of the Quality team and report to the Quality Engineer.
Function and objective of the position:
The main function of this role is to perform quality control inspections in the production floor for line clearance, products, production processes, approval of labels and batch documentation checks etc. as per relevant procedures.
Essential duties and responsibilities include:
- First line point of contact for in-line Quality queries – escalate to quality engineer / quality manager as appropriate
- Perform start up and in process inspections for production
- Accurately document the results of the inspections and testings
- Track and trend in process results for all relevant products where applicable
- Accurately document the results of the inspections and testings.
- Perform Environmental Monitoring as per procedure
- Support the Cleaning Process including documentation provision and record retention
- Act as back up for sterilization load inspection
- Maintain and file paperwork on a weekly basis, ensure all batch paperwork are filed in organizational and timely manners. Scan and send to batch release QA in building 2
- Work closely with quality engineers to complete testing for Complaints, CAPA and NCRs.
- Work closely with other functions to complete testing for validation, engineering change and new product introduction projects when required.
Qualifications
- Minimum degree in level 6 or equivalent is essential. Science or Engineering discipline preferred.
- 1-2 years’ experience working in a medical device environment, relevant quality experience would be an advantage.
- Knowledge of the Medical Device manufacturing environment including GMP/GDP would be an advantage.
- Good attention to details. Able to follow oral and written directions and understands concepts/requirements of testing, observing and preparing reports
- Good laboratory and analytical skills.
- Demonstrable organizational and problem solving skills.
- Good verbal communication skills.
- Good technical writing skills
- Adaptive & capable of working in a fast paced & dynamic environment.