Supplier Quality Engineer II

4 weeks ago


Hialeah, United States CareerBuilder Full time

(This is an 11-month contract with potential to extend/convert)

Responsibilities may include the following and other duties may be assigned:
Ensures that suppliers deliver quality parts, materials, and services.
Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier related problems as they occur.
Builds a collaborative relationship with suppliers to quickly address any non-conformances.
Drive appropriate root cause investigations with the supplier. Ensure corrective actions are implemented and monitor for desired results.
Work with the supply base to drive corrective/preventative action.
Based on feedback from incoming inspection, company/supplier internal quality metrics and customer complaints.
Review/prepare test plans and reports (qualification, validation) for change and improvement activities (supplier certifications, material/sub-supplier changes and supplier performed special processes).
Collaborates with the operating platform to address issues and gain alignment when required.
Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
Define Receiving Inspection requirements as required and associated test method validation for all internal Test Methods.
Lead PPAP execution with supplier and ensure robust supplier process qualification/validation through IQ, OQ & PQ methodology
Perform supplier audits.

Must Have:
Bachelors degree in Engineering
Change Control
Develop/Update PFMEA, Control Plans and Process Flows
Experience with multiple root cause investigation techniques
Managed the PPAP activities

Nice To Have:
Certifications: ISO 13485 Lead Auditor
Familiarity with medical device regulations and good manufacturing practices
Manage Supplier Change Requests
Previous SQE experience

2 openings
W2 Contract starting 11-months
Hybrid in Miami Lakes, FL (2 days/week remote)
Hours: 40 hours per week
Pay Range: $28-38/hr

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