JT042 - SUPPLIER QUALITY ENGINEER

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• Increase of volume of SQ activities related to business growth, increase capacity to supplier base, qualification of new tooling, and yield improvement efforts.
• 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.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Partners with cross functional teams (R&D, sourcing, engineering, operations, quality) to deliver quality parts, materials, and services, prevent defects, and allow client  to provide customers with the highest quality and reliable products.
• Provides technical guidance and quality compliance throughout the product lifecycle, with focus on supplier changes, and implements strategies for driving product quality and continuous improvement.
• Ensures purchased products and components are manufactured and qualified in accordance with applicable industry standards, regulatory requirements, and customer requirements.
• Collaborates with cross functional teams to develop and deliver:
  • Product Acceptance Sampling Strategy
  • Approved Supplier List coordination
  • Supplier Owned Quality deployment
  • Control Plans for new products
• Defines Receiving Inspection requirements as required.
• Supports associated test method validation for all internal Medtronic Test Methods.

Qualifications:

• Bachelor’s degree in related area
• 4 years of relevant experience, or an advanced degree with a minimum of 2 years relevant experience.
• Demonstrated experience in Medical Device Industry
• May have practical knowledge of project management.
• Experience using Agile and Trackwise would be a plus.
• Knowledge of ISO 13485 requirements.
• Knowledge of FDA QMSR.
• Knowledge of Geometric Tolerances.