Establishes and maintains appropriate Quality Systems consistent with ISO13485 and FDA 21CFR Part 820. Assures compliance to in-house and/or external specifications and standards. Actively leads the data collection, trend analysis, investigation and improvements to processes, products and systems.
- Work closely with Production, Technical and Manufacturing Engineering to resolve quality related issues arising from customer complaints/concerns and internal incidents. Responsible for the facilitation of investigations and resolution of related quality issues.
- Works with technical support and manufacturing to create and/or modify methods and procedures to ensure that appropriate processes and/or products are developed, tests are conducted and that products, materials, and manufacturing equipment meet required standards.
- Constantly strive to enhance efficiency in procedures and processes without a compromise in quality. Identify and implement opportunities for improvement across the operational facility.
- Performs statistical analysis to analyze trends, and works with manufacturing to investigate trends, conduct root cause analysis and lead corrective actions for processes and products.
- Maintain working knowledge of Regulatory and Quality System requirements (ISO13485/FDA CFR).
- Utilise the Trackwise system for non conformances, deviations, Corrective and Preventative Actions (CAPA).
- Participates on the Internal Quality Audit team.
- Assures compliance to in-house and/or external specifications to standards, such as GMPs and ISO regulations, and approves disposition for non-conformances on raw materials and finished goods.
- Provide training and support to other QA staff as required.
- Perform independently without continual direction and exercise considerable latitude in determining technical objectives and solutions to complex problems.
- May be required to perform other related duties as required and/or assigned.
*LI - KP1