We are on the hunt for an experience QA engineer who is available to take on a new role in an international Medical Device CMO who are expanding their operations in the Czech Republic. The main purpose of this role will be to support the Quality Manager in establishing, implementing and maintaining the QMS system. The company is currently transferring two semi-automated production lines from sites in other European countries to their Czech facility. There are two major projects with more projects in the pipeline. They will be looking to fully automate both these and some of the existing lines at the site so the candidate will need to have very strong technical background (ideally experience with manufacturing processes).
Ideal candidates will have a Bachelor Level qualification (or equivalent experience) in Engineering or a technical field. Injection Moulding manufacturing process experience would be considered a strong bonus, but this is not critical. The candidate will need to have GMP, QMS (ISO13485, 21CFR820), risk management (ISO14971) and cleanroom/ microbiology experience. This person will also need to have EXCELLENT communication skills, be resilient in a pressured environment.
Main responsibilitie will include:
- Ensuring QMS compliance
- Continual Improvement of the QMS
- QMS training responsibilities
- Handling of ‘’’Out Of Specification’’ results
- Solving of internal non-conformities and planned deviations
- Maintain the associated databases
- Maintain the areas for non-conforming products
- Rework activities (cost of poor quality)
- Assure compliance with Quality standards
- Represent Quality in daily/ weekly meetings
- Review incoming, in-process sampling / control plans
- Link engineering and production to ensure compliance with client requirements
- Coordinate new process techniques that improve efficiencies
- Perform root cause analysis alongside technical team, implement CAPAS and improve processes to reduce variability
- Cooperate with technical staff in performing of FMEA
- Cooperate with SCAR handling issued based on NCR reports
- Improve process for supplier data submission to reduce internal inspections
- Cooperate with dispatch or scrapping of nonconforming products
Interested candidates must be Ethical, open minded, diplomatic. Minimum 3yrs working in Medical Device field.