Quality Assurance Specialist
We are seeking a seasoned Quality Assurance Specialist to join our team. As a key member of the quality assurance department, you will be responsible for ensuring that all products meet user, regulatory and ISO 13485 requirements.
Key Responsibilities:
* Provide quality support during in-house manufacture and lot release
* Development of quality plans, programs and procedures for commercialisation
* Maintain compliance with Quality Management System (QMS) standards
* Evaluate product performance against company customer and regulatory requirements
* Analyse data on discrepancies related to product design and manufacture
* Sustain strong relationships with OEM contractors/vendors during component manufacturing
* Aid in preparation of responses to non-conformity reports during audits by regulatory agencies including FDA and Notified Body
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