JT047 - SUPPLIER QUALITY ENGINEER

Quality Consulting Group, LLC; Puerto Rico; Hybride; USD 85 000 - 110 000; Plein temps

Résumé du poste

Quality Consulting Group, LLC seeks a skilled professional to manage supplier quality in a world-class manufacturing context in Puerto Rico and the USA. You will ensure supplier performance, drive quality compliance, and collaborate with R&D, sourcing, and operations to support customers with reliable products.

The role emphasizes in‑depth knowledge of ISO 13485, Agile practices, and TrackWise, with cross‑functional teamwork to sustain high quality throughout the product lifecycle.

Qualifications

• Bachelor’s degree in related area.
• 4 years of relevant experience, or an advanced degree with a minimum of 2 years relevant experience.
• Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
• Demonstrated experience on Medical Device Industry or Automotive part qualification requirements.
• Experience using Agile and Trackwise would be a plus.
• Knowledge of ISO 13485 requirements.

Responsabilités

• Ensures that suppliers deliver quality parts, materials, and services.
• Qualifies suppliers according to company standards and may administer a Certified Supplier Program.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Partners with cross functional teams (R&D, sourcing, engineering, operations, quality) to deliver quality parts, materials, and services.
• Provides technical guidance and quality compliance throughout the product lifecycle with focus on supplier changes.
• Collaborates with cross functional teams to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, and related quality deployment.
• Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.

Connaissances

Supplier quality

Quality systems

Agile

TrackWise

ISO 13485

Formation

Bachelor’s degree in related area

Description du poste

QUALITY CONSULTING GROUP, a leader inthe 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

• Responsibilities may include the following and other duties may be assigned.
• Ensures that suppliers deliver quality parts, materials, and services.
• Qualifies suppliers acco rding 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 feedbackn 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 MiniMed to provide customers with the highest quality and reliable products.
• Provides technical guidance and quality compliance throughout the product lifecycle (with focuson supplier changes) and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
• Collaborates with cross functional teams 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 Medtronic Test Methods.
• Required skills in order to successfully perform this role

Qualifications

• Bachelor’s degree in related area
• 4 years of relevant experience, or an advanced degree with a minimum of 2 years relevant experience.
• Requires advanced knowledge of job area combining breadth and depth, typically obtained
  through advanced education combined with experience.
• Demonstrated experience on Medical Device Industry or Automotive part qualification
• requirements
• May have practical knowledge of project management.
• Experience using Agile and Trackwise would be a plus
• Knowledge of ISO 13485 requirements

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.