Supplier Quality Engineer

Role: Supplier Quality Engineer

Location: Santa Clara, CA

Job Description:

• Collaborate with the Supplier Quality Engineer (SQE) who owns the CAPA.
• Conduct root cause analysis, process mapping, and identify corrective actions for 1-2 CAPAs.
• Independently manage the remaining CAPA tasks and meet with the necessary stakeholders to gather information.
• Write technical documents to support CAPA completion.
• Identify gaps in processes, propose corrective actions, and drive CAPA to completion
• Work onsite, engaging with cross-functional teams to ensure timely CAPA closure.

Experience Required:

• Experience with 5 years as a Quality Engineer with substantial CAPA experience.
• Practical experience owning CAPAs and driving them to closure- Must have independently managed CAPAs, worked closely with stakeholders, and performed technical tasks to drive CAPAs to completion.
• Practical experience managing projects, but not necessarily PMI-certified
• Experience working with cross-functional teams and process mapping (e.g., value-stream map)
• Ability to write concise process documentation (e.g., SOPs, WIs, FRMs)
• Strong writing abilities, particularly for CAPA reports and quality documentation.
• ISO 13485 Knowledge: Familiarity with medical device quality standards and regulatory requirements.

Skills:

• Supplier Quality experience, including supplier auditing and process improvement and CAPA.
• Project Management experience: 2-3 years, with a combination of technical and project management responsibilities.