Sr Supplier Qual Engineer - Exempt

Position Summary

We are seeking a highly motivated Supplier Quality Engineer (SQE) to support supplier quality management activities across both New Product Development (NPD) and commercial manufacturing environments. This role is responsible for ensuring suppliers consistently deliver high-quality components, materials, and services that meet regulatory, quality, and business requirements.

The Supplier Quality Engineer will serve as a key liaison between suppliers, Engineering, Manufacturing, Operations, and Quality organizations to drive supplier performance, ensure compliance with Good Manufacturing Practices (GMP), and support the successful transfer of new products into production. The individual will provide technical leadership throughout the supplier qualification process, supplier audits, risk management activities, incoming inspection strategies, and continuous improvement initiatives.

This position requires strong expertise in supplier quality systems, quality engineering principles, risk-based decision making, and cross-functional collaboration within a regulated medical device environment.

Join us in Minneapolis, MN, a vibrant city known for its thriving medical device industry and a great quality of life. Experience a dynamic work environment where innovation and collaboration are at the forefront.

Key Responsibilities

Supplier Quality Management

• Ensure suppliers consistently provide quality products, materials, and services that meet company specifications and regulatory requirements.
• Lead supplier qualification, onboarding, and approval activities.
• Evaluate supplier capabilities, manufacturing processes, quality systems, and operational effectiveness.
• Manage and maintain Approved Supplier Lists (ASL).
• Support implementation and management of Supplier Owned Quality (SOQ) programs.
• Develop supplier performance metrics and drive supplier quality improvements.

Supplier Auditing & Compliance

• Develop, prioritize, and execute supplier audit schedules based on risk and business needs.
• Conduct supplier audits to assess compliance with:
  • GMP requirements
  • ISO 13485
  • FDA Quality System Regulations
  • Internal quality requirements
• Identify audit findings and work with suppliers to implement corrective actions.
• Verify effectiveness of supplier corrective actions and closure activities.
• Monitor supplier compliance and quality performance trends.

Supplier Issue Resolution

• Investigate supplier-related quality issues and nonconformances.
• Lead root cause investigations using structured problem-solving methodologies.
• Partner with suppliers to develop and implement corrective and preventive actions (CAPA).
• Escalate critical supplier quality risks when necessary.
• Support containment activities and material disposition decisions.

Pre-Market Supplier Quality Support (New Product Development)

• Provide Supplier Quality Engineering support throughout the New Product Development (NPD) lifecycle.
• Collaborate with Component Engineering, Design Engineering, Manufacturing Engineering, and Post-Market Supplier Quality teams.
• Support supplier selection and qualification for new products.
• Ensure purchased materials and components meet design, regulatory, and customer requirements.
• Participate in design reviews and risk assessments.
• Drive defect prevention and proactive quality planning activities.

Product Acceptance & Inspection Strategy

• Collaborate with engineering teams to develop:
  • Product Acceptance Sampling Plans
  • Receiving Inspection Strategies
  • Control Plans
  • Inspection Requirements
• Define incoming inspection methodologies and acceptance criteria.
• Support risk-based inspection reduction initiatives where applicable.
• Develop and validate inspection and test methods.

Risk Management & Quality Planning

• Participate in supplier risk assessments and mitigation planning.
• Support PFMEA and supplier-related risk management activities.
• Evaluate quality risks associated with new suppliers, materials, and manufacturing processes.
• Implement preventive quality strategies to reduce supplier-related defects.

Continuous Improvement

• Analyze supplier quality data and identify trends.
• Lead continuous improvement projects focused on:
  • Defect reduction
  • Process capability improvement
  • Cost reduction
  • Supplier performance enhancement
• Recommend process, system, and product improvements.

Project Leadership & Technical Expertise

• Independently manage supplier quality projects and initiatives.
• Provide technical leadership on complex supplier quality challenges.
• Mentor junior engineers and quality professionals.
• Support cross-functional project teams in achieving program milestones.
• Influence supplier and internal stakeholder decisions through technical expertise and data-driven recommendations.

Required Qualifications

Education

• Bachelor’s Degree in:
  • Engineering
  • Mechanical Engineering
  • Biomedical Engineering
  • Industrial Engineering
  • Manufacturing Engineering
  • Quality Engineering
  • Related technical discipline

Experience

• Minimum 4 years of relevant Supplier Quality, Quality Engineering, Manufacturing Quality, or Product Quality experience.
• OR Advanced Degree with minimum 2 years of relevant experience.
• Experience within a regulated industry such as:
  • Medical Devices
  • Biotechnology
  • Pharmaceuticals
  • Diagnostics
  • Aerospace
  • Automotive