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Quality Assurance Specialist
2 months ago
Katalyst HealthCares & Life Sciences is seeking a highly skilled Quality Assurance Specialist to lead our quality assurance activities and ensure the highest levels of quality in our products.
Key Responsibilities- Technical Leadership: Provide technical leadership and direction in quality assurance, quality control, and preventative activities to ensure the development of robust, predictive quality systems.
- Design for Manufacture and Assembly: Support the development and introduction of new products, processes, and technologies, with a focus on quality systems development, regulatory compliance, and process risk management.
- Process Development: Develop and characterize processes that are capable, scalable, and produce high yield, and support the design of robust inspection strategies.
- Risk Management: Proficient in risk management practices and tools, with high expertise in failure modes associated with production and production-related processes.
- Quality Engineering Support: Provide manufacturing quality engineering support for the execution of quality assurance activities during design transfer phases of new product development.
- Compliance and Regulations: Ensure all Risk Management outputs comply with ISO standards and support the required stages defined in the product and process design cycle.
- Measurement System Analysis: Develop Measurement System Analysis (MSA) strategy and approve executed MSAs.
- Lean Inspection Strategies: Develop and implement lean inspection strategies and inspection plans through state-of-the-art inspection methods and technologies.
- Continuous Improvement: Lead continuous improvements of inspection methods and sampling plans, with a focus on human error risk elimination.
- Validation Strategies: Support the development, execution, and approval of validation strategies, with the goal of highly capable processes that result in high yield and enable scalability.
- Supplier Qualification: Lead the supplier qualification strategy and approve the supplier validations and Production Part Approval Process (PPAP).
- Communication: Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet the NPI project goals.
- Education: Bachelor's degree in Manufacturing, Industrial Engineering, or a related field.
- Experience: Previous experience in engineering or project management is typically required, with a minimum of [X] years of experience in quality assurance and process development.
- Skills: Proficient in risk management practices and tools, with high expertise in failure modes associated with production and production-related processes, and experience in ISO-certified and cGMP organizations.
