Job Title: Supplier Quality Engineer

Location: San Francisco Bay Area, CA

Duration: 12months

Key Responsibilities:

• Qualify and manage suppliers to meet quality and regulatory standards (FDA, ISO 13485).
• Conduct supplier audits and track performance using scorecards.
• Investigate supplier quality issues and lead root cause analysis and corrective actions.
• Support new product development by ensuring suppliers are ready and capable.
• Review and maintain supplier quality documents and agreements.
• Work with internal teams on quality improvements and risk assessments.
• Help prepare for internal and external audits.

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• At least 7 years of experience in supplier quality in the medical device industry.
• Strong knowledge of FDA regulations and ISO 13485.
• Experience with CAPA, SCAR, FMEA, and validation (IQ/OQ/PQ).
• Good understanding of manufacturing processes and quality systems.
• Strong communication, teamwork, and problem-solving skills.
• Quality certifications (like ASQ CQE or CSQP) are a plus.