Job Title:
A Quality Assurance Professional is required to initiate and perform defined quality activities leading to new or improved processes or systems.
The role involves:
* Initiating, reviewing, and approving change controls
* Maintaining compliance for Product Manufacturing, Packaging, and Labeling
* Developing a strategy and implementing appropriate sampling methods
* Writing and reviewing CAPAs, NC/NCMRs, and SCARs to address compliance issues and providing guidance to suppliers and engineering teams
* Performing Internal and Supplier Audits
* Supporting and participating in external regulatory body audits, including ISO and FDA
* Ensuring adherence to CGMP requirements and relevant associated documentation
Key Skills and Qualifications:
* Degree-level qualification in Quality, Science, or Engineering is required
* Minimum Three (3) years of experience working in regulated environments, specifically medical device, FDA, or ISO 13485 registered work environments is preferred
* Medical device change control implementation experience
* Strong computer skills (MS Excel, PowerPoint, Word)
* Familiarity with statistical tools such as Pareto charts and trend charts
* Familiarity with FMEA's (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
About the Role:
* Global medical Device company
* Hybrid working model
* Career advancement opportunities
* Flexibility to work with different teams within other manufacturing units