Senior Supplier Quality Engineer

Pyramid Consulting•Remote (Puerto Rico or US East Coast), CA
•Remote

About The Position

Pyramid Consulting is recruiting a Senior Supplier Quality Engineer for a 12+ month contract opportunity with long-term potential. The position is remote in the U.S. and supports a leading medical device manufacturing client. The engineer ensures supplier quality throughout acquisition and manufacturing, qualifies and audits suppliers, and addresses supplier-related issues through the Supplier CAPA process. Some individuals may also provide pre-market supplier quality support to New Product Development and collaborate with Distribution on distributor and 3PL selection.

Requirements

  • Bachelor’s degree in engineering.
  • At least 4 years of relevant experience, or an advanced degree and at least 2 years of relevant experience.
  • Experience in Supplier Quality Engineering and supplier audits.
  • Experience with CAPA, root cause analysis, and corrective actions.
  • Experience working with Distribution Centers and 3PL suppliers.
  • ISO 13485 Lead Auditor Certification.
  • ASQ CQE, Six Sigma, or another continuous improvement methodology certification.
  • Experience leading projects.

Nice To Haves

  • Experience with SAP, Agile, and Trackwise.

Responsibilities

  • Ensure suppliers deliver quality parts, materials, and services.
  • Qualify suppliers according to company standards and potentially administer a Certified Supplier Program in receiving inspection to support cost effectiveness.
  • Monitor parts from acquisition through the manufacturing cycle and communicate and resolve supplier-related problems through the Supplier CAPA process.
  • Develop and prioritize an auditing schedule to audit designated suppliers regularly for good manufacturing practices (GMP) and quality standards.
  • Evaluate suppliers’ internal functions, assess overall performance, and provide feedback about their operations.
  • For roles with pre-market responsibilities, provide Pre-Market Quality Engineering support to New Product Development in partnership with Component Engineering, Post-Market Supplier Quality, and Distribution teams.
  • Collaborate with Distribution on selecting new distributors and 3PLs.
  • Define receiving inspection requirements and associated test method validation as required.

Benefits

  • Health insurance, including medical, dental, and vision coverage.
  • 401(k) plan.
  • Paid sick leave, depending on work location.
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