The Quality Manager is responsible for providing quality assurance leadership in the management of suppliers to the Medical Device market. Responsible for providing supplier quality engineering support including managing supplier performance. The Quality Engineer will be leading project initiatives through project activities such as New Product Introduction, Qualification and Validation.
- The Quality Manager will provide support for the introduction of new components and component changes.
- Assume full responsibility for a product launch and/ or transfers from one of the strategic suppliers
- The Quality Manager is responsible for managing CAPA interface between supplier and customer –
- Drive out root cause and corrective actions associated with CAPAs.
- The Quality Engineer will lead the Quality System review from a Supplier Quality perspective
- Engage with external customers/contacts include outside technical contractors, suppliers, consultants, second and third part auditors.
- Provides guidance to Purchasing/Logistics, Technical team and relevant stakeholders in applying supplier quality system requirements.
- Bachelor's Degree in Engineering, Life Science, or related discipline.
- Minimum 5-6 years’ experience in a Quality or Engineering Function within a Medical Device Company.
- Experience in the medical device, biotech and/or pharmaceutical industry is preferred.
- ISO regulations knowledge is required, ISO 13485 knowledge is preferred
- Previous experience of product transfers/start up desired
- Strong communication, teamwork, and problem solving skills are required.
- Possess knowledge of statistical analysis tools (Minitab SAS preferred).
- Strong project/time management experience
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