- Day to day inspection criteria for inspecton and release of medical device products and associated components
- documentation of release activities in line with local QMS procedure requirements
- Support process improvements and validation activities
- Working within the QA team to support improvement activities
- Engineer/Science qualification with minimum of 2 years working within QA in a multi-national medical devices manufacturing environment.
- Knowledge of ISO 13485 and 21CFR820 and MDSAP program, along with exposure to other regulations.
- Experience in dealing with Operations to support plant attainment.
- Support to the Ena=gineering department on the execution of validation protocols
- Attention to detail and accuracy – essential.
- Ability to work well under deadlines and pressure.
- Strong skills for developing creative solutions and meeting objectives are required.
- Experience in internal auditing to QSRs and ISO 13485 requirements an advantage.
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