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Quality Assurance Specialist
2 weeks ago
Job Title: Quality Assurance Specialist
About the Role:
The primary function of a Quality Assurance Specialist is to execute and implement quality control activities, leading to new or improved processes. Key responsibilities include initiating, reviewing, and approving change controls, ensuring compliance for product manufacturing, packaging, and labeling, developing strategies for sampling methods, and writing reviews of CAPAs, NC/NCMRs, and SCARs to address compliance issues.
- Degree level qualification in Quality, Science, or Engineering;
- Minimum Three (3) 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;
- Ability to work within a fast-paced team environment.
Benefits:
- Global medical Device company;
- Hybrid working model;
- Career advancement opportunities;
- Flexibility to work with different teams within other manufacturing units.
