Supplier Quality Engineer II, Medical Device

Found in: Appcast Linkedin GBL C2 - 3 weeks ago


Miami Lakes, United States Planet Pharma Full time

2 openings

W2 Contract starting 11-months

Hybrid in Miami Lakes, FL: 2-days per week remote

Benefits available through Planet Pharma

Hours: 40 hours per week


Top 3 technical skills that are required for the role:

  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, 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

  • Bachelor’s 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



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