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Leading Quality Assurance Specialist
3 weeks ago
We are seeking a highly skilled Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality engineering and be able to initiate and perform defined quality activities leading to new or improved processes or systems.
About the Role:The successful candidate will be responsible for ensuring compliance is maintained for product manufacturing, packaging and labeling. They will develop a strategy and implement appropriate sampling methods, write up and review of CAPAs, NC/NCMRs and SCARs to address compliance issues and provide guidance to suppliers and engineering.
- Initiating, reviewing and approving change controls
- Ensuring compliance is maintained for Product Manufacturing, Packaging and Labeling
- Developing a strategy and implementing appropriate sampling methods
- Writing up and reviewing of CAPAs, NC/NCMRs and SCARs to address compliance issues
- Providing guidance to suppliers and engineering
To be successful in this role you will need:
- Degree level qualification in Quality, Science or Engineering
- Minimum three years experience working in a regulated environment, specifically medical device, FDA or ISO 13485 registered work environments
- Medical device change control implementation
- Strong computer skills (MS Excel, PowerPoint, Word etc.)
- Familiarity with statistical tools such as Pareto charts and trend charts
- Familiarity with FMEAs (Failure Mode and Effects Analysis) and root cause analysis tools
- Experience with problem solving techniques
- Ability to effectively communicate technical information, both verbally and in writing, to both non-technical and technical associates
We offer a range of benefits including:
- Global company with opportunities for career advancement
- Hybrid working model
- Career advancement opportunities
- Flexibility to work with different teams within other manufacturing units
