This is a role in Quality Assurance focusing on ensuring the quality and reliability of our supply chain for medical device components. You will be responsible for assessing, qualifying, and managing suppliers to meet regulatory requirements and uphold our company's standards for product quality.
Duties and Responsibilities
- Evaluate potential suppliers through audits, assessments, and qualification processes to ensure compliance with regulatory standards (e.g., ISO 13485, FDA, MDD/MDR etc.)
- Develop and implement supplier quality agreements, specifications, and standards to maintain consistent quality and reliability of supplied components.
- Collaborate with cross-functional teams, including procurement, engineering, and manufacturing, to resolve supplier-related quality issues and drive continuous improvement initiatives.
- Conduct regular supplier performance reviews, track key quality metrics, and implement corrective and preventative actions (CAPAs) to address non-conformances.
- Participate in supplier selection processes, providing quality engineering expertise to ensure suppliers meet established quality and performance criteria.
- Lead or contribute to risk assessments related to supplier processes and materials, identifying potential risks and implementing risk mitigation strategies.
- Participate in the Material Review Board (Non-conforming material investigation and disposition), Corrective Action Board (Failure Analysis and CAPA), and Audit process (Internal and External Audits).
- Review and approve test and validation documents, receiving inspection requirements, sampling plans and Change Orders for product and process changes.
- Initiate change orders to correct drawings, specifications, and Quality System Procedures.
- Will be required to perform other work-related duties as requested, directed or assigned by management.