Supplier Quality Engineer

Sira Consulting, an Inc 5000 company; Deer Creek (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Sira Consulting seeks a Supplier Quality Engineer in Minnesota to ensure suppliers deliver quality materials and services for medical devices in compliance with regulatory requirements. You will manage supplier qualifications, ASL onboarding, and documentation.

The role requires extensive experience with PPAP, DFMEA, PFMEA, MSA, and process validation, and collaboration with global teams. You will use PLM and quality tools to route and secure approvals, driving continuous supplier quality

Qualifications

• Bachelor's degree in engineering, technical, or scientific field.
• Minimum 8 years of experience in supplier quality within medical devices.
• Strong knowledge of regulatory standards, quality systems, and supplier quality processes.
• Experience with PPAP, risk management, process validation, and quality tools (DFMEA, PFMEA, MSA).

Responsibilities

• Ensure suppliers deliver quality parts, materials, and services meeting Medtronic requirements.
• Evaluate and onboard new suppliers into the Approved Supplier List (ASL).
• Perform product and feature-level quality impact assessments and documentation.
• Review and approve PPAP documentation including Control Plans, Process Flow Charts, Process Drawings, Capability Studies, DFMEA, and PFMEA.
• Facilitate Supplier Quality Agreements and conduct supplier audits.
• Coordinate supplier evaluation and selection activities for new suppliers or changes to existing products/processes.
• Support and approve Process Validation activities (IQ, OQ, PQ), MSA/TMV, and Control Plans.
• Route documentation in PLM systems and follow up for approvals and release.
• Collaborate with Global Supplier Quality teams to implement Supplier Data Review (SDR) / Supplier Owned Quality (SOQ) activities.

Skills

Analytical skills

Problem-solving

Communication

Stakeholder management

Cross-functional collaboration

Quality mindset

Education

Bachelor's degree in engineering/technical/scientific field

Tools

PLM systems

PPAP

DFMEA

PFMEA

MSA

Process validation

Job description

Supplier Quality Engineer is responsible for ensuring suppliers deliver quality materials, components, and services in compliance with regulatory and organizational requirements within the medical device industry.

Key Responsibilities:

• Ensure suppliers consistently deliver quality parts, materials, and services meeting Medtronic requirements.
• Evaluate and onboard new suppliers into the Approved Supplier List (ASL).
• Perform product and feature-level quality impact assessments and maintain necessary documentation.
• Review and approve PPAP documentation including Control Plans, Process Flow Charts, Process Drawings, Capability Studies, DFMEA, and PFMEA.
• Facilitate Supplier Quality Agreements and conduct supplier audits.
• Coordinate supplier evaluation and selection activities for new suppliers or changes to existing products/processes.
• Support and approve Process Validation activities (IQ, OQ, PQ), MSA/TMV, and Control Plans.
• Route documentation in PLM systems and follow up for approvals and release.
• Collaborate with Global Supplier Quality teams to implement Supplier Data Review (SDR) / Supplier Owned Quality (SOQ) activities.

Qualifications & Experience:

• Bachelor’s degree in engineering, Technical, or Scientific discipline.
• Minimum 8 years of experience in Supplier Quality or related roles within the Medical Device industry.
• Strong knowledge of regulatory standards, quality systems, and supplier quality processes.
• Experience with PPAP, risk management, process validation, and quality tools (DFMEA, PFMEA, MSA).

Skills:

• Strong analytical and problem-solving skills.
• Excellent communication and stakeholder management abilities.
• Ability to work collaboratively with cross-functional and global teams.
• Proficiency in PLM systems and quality documentation tools.