Supplier Qual Engineer II

Medtronic•Villalba, PR

About The Position

The Supplier Quality II supports sustaining activities for Manufacturing Operations by evaluating non-conforming components from external suppliers. The role ensures suppliers deliver quality parts, materials, and services, and may qualify suppliers to company standards or administer a Certified Supplier Program in receiving inspection. Some positions may also include Pre-Market Supplier Quality responsibilities. In that capacity, the role supports New Product Development (NPD) with Component Engineering and Post-Market Supplier Quality, providing technical guidance and quality compliance throughout the NPD lifecycle. The work focuses on qualifying new parts, preventing defects, driving product quality and continuous improvement, and ensuring purchased products and components meet applicable industry standards, regulatory requirements, and customer requirements. The position requires a bachelor’s degree in engineering and at least two years of relevant experience, or a master’s degree with no minimum relevant experience. For baccalaureate degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Requirements

  • Bachelor’s degree in engineering and a minimum of 2 years of relevant experience, or a master’s degree with a minimum of 0 years of relevant experience.
  • For baccalaureate degrees earned outside the United States, a degree satisfying the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

  • Experience qualifying suppliers, manufacturing processes, materials, or components.
  • Experience applying quality tools such as root cause analysis, Corrective and Preventive Action (CAPA), risk management, or statistical analysis.
  • Knowledge of supplier quality systems, auditing practices, and quality control methodologies.
  • Experience working within regulated industries and quality management systems.

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 ensure cost effectiveness.
  • Monitor parts from acquisition through the manufacturing cycle and communicate and resolve supplier-related problems.
  • Develop and prioritize an auditing schedule to audit designated suppliers regularly for compliance with good manufacturing practices (GMP) and quality standards.
  • Evaluate suppliers’ internal functions to assess their overall performance and provide feedback on their operations.
  • For roles with Pre-Market Supplier Quality duties, provide Pre-Market Quality Engineering support to New Product Development in partnership with Component Engineering and Post-Market Supplier Quality.
  • Provide technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle for newly qualified parts.
  • Implement strategies for product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified to applicable industry standards, regulatory requirements, and customer requirements.
  • Collaborate 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 needed and associated test method validation for internal Medtronic Test Methods.

Benefits

  • Competitive salary and flexible benefits package.
  • Wide range of benefits, resources, and competitive compensation plans designed to support employees at every career and life stage.
  • Eligibility for the short-term Medtronic Incentive Plan (MIP).
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