Supplier Quality Engineer
Supplier Quality Engineer
Posted on :
13-04-2025
Employer Active
1 Vacancy
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Job Description
Work Flexibility: Hybrid
What you will do:
- Collaborates with suppliers to assure the quality of their products materials components and/or operations.
- Analyze supplier performance data and metrics (e.g. DPM failure modes trending etc.
- Provide input to Sourcing Site SQEs and commodity team on supplier performance
- Responsibilities related to Supplier Quality and Change Management Continuous Improvement Identify areas of process and system improvement Propose and implement changes
- Lead Supplier Audit (Must) and preventive CAPA to improve Supplier Quality
- Visit suppliers to resolve issues
- Issue Supplier Corrective Action Requests and ensure suppliers implement robust corrective action which prevent recurrence (CAPAs)
- Ensure timely and accurate documentation of auditready nonconformance records
What you will need:
Basic Qualifications:
- Bachelors degree in Engineering (Mechanical / Electrical / Electronics / BioMedical)
- Minimum of 26 years experience in Quality / Engineering / Manufacturing environment.
- Good knowledge with GMP ISO 13485 (Certification) 21 CFR Part 820 standards FMEA Validation Programs and SPC processes.
- Demonstrated working knowledge to influence positively the trend of the relevant supplier quality metrics.
- Strong analytical problemsolving capabilities and communication skills.
- Willing to travel in support of business needs to different geographical locations.
Preferred Qualifications:
- Working experience in medical device industry is preferred.
- Lead Quality Auditor Qualification in ISO13485 CFR820 or comparable industry standards and regulatory requirements
- ASQ CQE/CQM/PE certification
Employment Type
Full-Time
Key Skills
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