JT042 - SUPPLIER QUALITY ENGINEER

qualityconsultinggroup; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

QUALITY CONSULTING GROUP is seeking a talented professional to join our team in the medical device sector in Puerto Rico & USA. You will lead supplier quality activities, drive continuous improvement, and ensure compliance with ISO 13485 and FDA QMSR.

This role emphasizes supplier base expansion, risk mitigation, and adherence to regulatory requirements across product lifecycles. Work with cross‑functional teams, qualify suppliers, and implement robust receiving inspection and test method

Qualifications

• Bachelor's degree is required
• 4 years of relevant experience, or advanced degree with 2+ years of relevant experience
• Experience in Medical Device Industry
• Agile and TrackWise a plus
• ISO 13485 knowledge
• FDA QMSR knowledge
• Geometric tolerances knowledge

Responsibilities

• Increase 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 clientto 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.

Skills

Agile

TrackWise

Quality systems

Supplier quality

Education

Bachelor's degree in related area

Job description

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

• 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 clientto 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.

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.