
Quality Assurance Specialist
2 days ago
This position is responsible for providing quality assurance support and direction in quality control, analysis, and process improvement activities within operations and other business functions.
Main Responsibilities:- Collaborate with operations and business functions to ensure quality performance of products and processes.
- Oversight and approval of NC & CAPA, active participation in problem-solving and root-cause analysis activities.
- Lead and participate in the development and improvement of manufacturing processes for existing and new products.
- Analyze and review concession requests.
- Review and approve change management activities.
- Maintain KPIs for monitoring process quality, perform analysis, and interpret trends.
- Support execution and analysis of QATs.
- Advocate for Human Factor practices, proficient in Human Factor identification and mitigation.
- Proficient in risk management practices and tools, with expertise in process risk.
- Develop and provide input for risk management by identifying opportunities and weaknesses.
- Optimize inspection methods and sampling.
- Support First Article Inspections.
- Apply statistical methods and techniques.
- Participate in internal and external audits with regulatory representatives.
- Assist in process and equipment validation/qualification.
- Support manufacturing transfers to other plants/facilities.
- Manage Ship, Product Holds, potential product escapes.
- Counsel and mentor others in quality topics and activities.
This role requires a strong background in quality engineering, risk management, and human factors. The successful candidate will be a leader who can drive continuous improvement and excellence in quality performance.
About the Role:This position offers an exciting opportunity to make a significant impact on the quality of our products and processes. If you are passionate about delivering high-quality results and improving processes, we encourage you to apply.
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