JT042 - SUPPLIER QUALITY ENGINEER

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Quality Consulting Group, LLC seeks a motivated professional to strengthen supplier qualification and quality systems in Puerto Rico and the U.S. You will interface with R&D, sourcing, engineering, and operations to drive continuous improvement and regulatory compliance in a dynamic medical device environment.

Responsibilities include defining supplier quality programs, coordinating in-process inspections, and ensuring adherence to ISO 13485 and FDA QMSR standards.

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.
• Experience with Agile and TrackWise is a plus.
• Knowledge of ISO 13485 requirements.
• Knowledge of FDA QMSR.
• Knowledge of Geometric Tolerances.

Responsibilities

• Increase SQ activities for business growth and supplier base qualification, and yield improvements.
• Ensure suppliers deliver quality parts, materials, and services.
• Qualify suppliers per company standards; may administer a Certified Supplier Program in receiving inspection.
• Monitor parts from acquisition through manufacturing and resolve supplier-related problems.
• Assess suppliers’ internal functions and provide performance feedback.
• Collaborate with R&D, sourcing, engineering, operations, and quality to deliver quality parts and services.

Skills

Quality mindset

Agile

TrackWise

Geometric tolerances

FDA QMSR knowledge

Education

Bachelor’s degree in related area

Tools

TrackWise software

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.