Overview
Remote
On-site
Job Description
Summary : We are seeking an experienced Supplier Quality Engineer (SQE) with a strong background in the Medical Device industry to support supplier quality, compliance, and process validation activities.
Key Responsibilities:- Ensure suppliers consistently deliver quality parts, materials, and services meeting company requirements.
- Evaluate and onboard suppliers into the Approved Supplier List (ASL).
- Review and approve PPAP documentation, Control Plans, Process Flow Charts, Capability Studies, DFMEA, and PFMEA.
- Conduct supplier risk assessments and maintain supplier risk profiles.
- Facilitate Supplier Quality Agreements and conduct supplier audits.
- Support Process Validation activities (IQ, OQ, PQ), MSA/TMV, and Control Plans.
- Coordinate supplier evaluation and selection activities for new suppliers and process changes.
- Manage documentation within PLM systems and ensure timely approvals and releases.
- Collaborate with global quality teams on Supplier Data Review (SDR) and Supplier Owned Quality (SOQ) initiatives.
- Bachelor's degree in Engineering, Technical, or Scientific discipline.
- 8+ years of Supplier Quality experience in the Medical Device industry Strong knowledge of quality systems, supplier quality processes, and regulatory requirements.
- Experience with PPAP, DFMEA, PFMEA, MSA, Risk Management, and Process Validation (IQ/OQ/PQ).
- Experience working with PLM systems and quality documentation tools.
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FAQs About Supplier Quality Engineer Jobs at Karwell Technologies
What is the work location for this position at Karwell Technologies?
This job at Karwell Technologies is located in Salt Lake City, UT, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Karwell Technologies?
Employer has not shared pay details for this role.
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