Job Title - Supplier Quality Engineer II - Exempt

Number of Positions - 2

Job Location - 1 Miami Lakes, Florida, United States

Job Description -

1. Production Parts Approval Process (PPAP)
2. Root Cause Investigation / CAPA
3. Change Control

What product line will this person support? Contract Manufacturers for HVAD products.

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, 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.