Supplier Quality Engineer

MG Staffing Group; Juncos (PR); On-site; USD 85,000 - 110,000; Full time

Job summary

MG Staffing Group is seeking an experienced Supplier Quality Engineer to ensure suppliers deliver high-quality parts, materials, and services that meet regulatory and customer requirements. This role partners with R&D, Sourcing, Engineering, Operations, and Quality across the product lifecycle.

You will qualify suppliers, manage receiving inspections, support supplier changes, and implement quality improvement initiatives with focus on GD&T, ISO 13485, and FDA QMSR requirements.

Qualifications

• Minimum 4 years of relevant experience; advanced degree reduces requirement to 2 years.
• Experience in Medical Device or Automotive part qualification requirements.
• Advanced knowledge of supplier quality, quality systems, manufacturing processes, and component qualification.

Responsibilities

• Qualify and evaluate suppliers according to company requirements and quality standards.
• Support supplier qualification, supplier changes, and receiving inspections.
• Monitor purchased parts from acquisition through manufacturing.
• Identify, communicate, investigate, and resolve supplier-related quality issues.
• Collaborate with R&D, Sourcing, Engineering, Operations, and Quality to prevent defects and ensure reliable, high-quality products.
• Define product acceptance sampling strategies, Approved Supplier List coordination, and supplier quality initiatives.
• Ensure purchased products and components meet industry standards, regulatory requirements, and customer expectations.
• Provide technical guidance and quality compliance throughout the product lifecycle.

Skills

Analytical skills

Problem-solving

Communication

Cross-functional collaboration

Education

Advanced degree (any field)

Tools

GD&T

ISO 13485

FDA QMSR

TrackWise

Agile

Job description

We are seeking an experienced Supplier Quality Engineer to ensure suppliers consistently deliver high-quality parts, materials, and services that meet company, regulatory, and customer requirements.

This position will partner with cross-functional teams, including R&D, Sourcing, Engineering, Operations, and Quality, to support supplier qualification, supplier changes, product quality, defect prevention, and continuous improvement throughout the product lifecycle.

Responsibilities

• Ensure suppliers deliver quality parts, materials, and services in accordance with established company standards.
• Qualify and evaluate suppliers according to company requirements and applicable quality standards.
• Support and/or administer Certified Supplier Programs and receiving inspection activities to improve quality and cost effectiveness.
• Monitor purchased parts and components from acquisition through the manufacturing cycle.
• Identify, communicate, investigate, and support the resolution of supplier-related quality issues.
• Evaluate supplier operations and internal quality systems to assess overall performance and provide appropriate feedback.
• Partner with cross-functional teams, including R&D, Sourcing, Engineering, Operations, and Quality, to prevent defects and ensure the delivery of reliable, high-quality products.
• Provide technical guidance and quality compliance support throughout the product lifecycle, with particular focus on supplier-related changes.
• Implement strategies to improve supplier and product quality while supporting continuous improvement initiatives.
• Ensure purchased products and components are manufactured and qualified according to applicable industry standards, regulatory requirements, and customer requirements.
• Collaborate with cross-functional teams to develop and implement Product Acceptance Sampling Strategies, Approved Supplier List coordination, Supplier Owned Quality initiatives, and Control Plans for new products.
• Define Receiving Inspection requirements as needed.
• Support test method validation activities for applicable internal test methods.
• Perform other duties as assigned.

Requirements

• Minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience.
• Demonstrated experience with Medical Device Industry or Automotive part qualification requirements.
• Advanced knowledge of supplier quality, quality systems, manufacturing processes, and component qualification.
• Knowledge of applicable regulatory and industry quality requirements.
• Strong analytical, problem-solving, communication, and cross-functional collaboration skills.
• Practical knowledge of project management is preferred.

Technical Skills

• Knowledge of ISO 13485 requirements.
• Knowledge of FDA Quality Management System Regulation (QMSR) requirements.
• Knowledge of Geometric Dimensioning and Tolerancing (GD&T).
• Experience with supplier and/or component qualification activities.
• Experience with receiving inspection requirements and test method validation.
• Experience using Agile is a plus.
• Experience using TrackWise is a plus.
• Willing to work 100% on site in Juncos, PR.