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Supplier Quality Engineer
2 months ago
Currently seeking Supplier Quality Engineers for a global, premiere healthcare leader with a portfolio of life-changing technologies and products in diagnostics, medical devices, nutritionals and branded generic medicines.
This is an onsite position in Pleasanton, CA – No Remote option avail, no C2C.
As a Supplier Quality Engineer, you will play a critical role in ensuring the quality and reliability of components and materials sourced from external suppliers for our heart failure related devices. Your expertise will be pivotal in maintaining high standards of product quality, compliance with regulatory requirements, and fostering strong relationships with our suppliers. Our products include Left Ventricular Assist Devices (LVADs), pressure monitors, Cardiac Resynchronization Therapy (CRT) devices, and other cutting-edge technologies.
Key Responsibilities:
- Evaluate and approve suppliers based on their ability to meet quality, delivery, and cost requirements. Conduct supplier audits and assessments as necessary.
- Collaborate with cross-functional teams including Engineering, Procurement, and Regulatory Affairs to establish quality requirements for new and existing suppliers.
- Implement and maintain supplier quality agreements, ensuring clear communication of expectations and responsibilities.
- Lead and support supplier corrective action processes (SCARs), including root cause analysis, corrective action implementation, and effectiveness verification.
- Monitor supplier performance through metrics and KPIs, identifying opportunities for continuous improvement and risk mitigation.
- Review and approve supplier documentation such as quality plans, inspection protocols, and certificates of compliance.
- Participate in new product development projects to ensure supplier quality requirements are integrated into design and manufacturing processes.
- Provide guidance and support to suppliers regarding quality standards, specifications, and regulatory requirements.
- Stay current with industry trends, regulations, and best practices related to supplier quality management in the medical device sector.
Qualifications:
- Bachelor’s degree in Engineering or related technical field; advanced degree welcomed.
- 3+ years of experience in Supplier Quality Engineering within the medical device industry desired.
- Strong knowledge of quality management systems (ISO 13485, FDA QSR) and regulatory requirements applicable to medical devices.
- Experience conducting supplier audits and assessments, with a focus on risk-based approaches.
- Proficiency in root cause analysis, CAPA methodologies, and statistical techniques.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across teams and with external stakeholders.
