Company:
Intellectt Inc
Location: Santa Clara
Closing Date: 27/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
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.
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