Supplier Quality Engineer

Katalyst CRO; Salt Lake City (UT); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO in Utah seeks an experienced Supplier Quality Engineer to lead supplier quality initiatives in the Medical Device sector. The role focuses on ensuring high-quality materials and components meet regulatory and internal standards, with expertise in PPAP, risk assessment, and quality systems.

The candidate will manage supplier onboarding, supplier audits, and CAPA activities, collaborating with cross-functional teams to maintain compliance and drive continuous improvement.

Qualifications

• Bachelor's degree in Engineering or related technical/scientific discipline.
• 8+ years of Supplier Quality Engineering experience in Medical Device.
• Strong understanding of FDA regulations, ISO 13485, and medical device QMS.
• Hands-on experience with supplier qualification, supplier development, and supplier quality management.
• Experience reviewing and approving PPAP documentation.

Responsibilities

• Manage supplier quality activities to ensure compliance with quality standards and regulatory requirements.
• Evaluate, qualify, and onboard new suppliers into the Approved Supplier List (ASL).
• Perform supplier assessments and quality evaluations for new products, components, and process changes.
• Review and approve PPAP documentation including DFMEA/PFMEA and Control Plans.
• Plan, coordinate, and perform supplier audits to ensure ongoing compliance.
• Collaborate with Global Supplier Quality teams to implement SDR and SOQ initiatives.
• Route quality documentation through PLM systems and ensure timely approvals and document releases.
• Investigate supplier quality issues, identify root causes, implement CAPA, and drive continuous improvement initiatives.

Skills

Supplier quality management

Process validation

Risk assessment

PPAP

Quality systems

Education

Bachelor's degree in Engineering or related

Tools

PLM systems

Job description

Summary

We are seeking an experienced Supplier Quality Engineer (SQE) to support supplier quality initiatives within the Medical Device industry. The ideal candidate will be responsible for ensuring suppliers consistently deliver high-quality materials, components, and services that comply with regulatory requirements and organizational quality standards. This role requires strong expertise in supplier quality management, process validation, risk assessment, PPAP, and quality systems.

Roles & Responsibilities

• Manage supplier quality activities to ensure compliance with company quality standards and regulatory requirements.
• Evaluate, qualify, and onboard new suppliers into the Approved Supplier List (ASL).
• Perform supplier assessments and quality evaluations for new products, components, and process changes.
• Conduct product and feature-level quality impact assessments and maintain supporting documentation.
• Review and approve Production Part Approval Process (PPAP) documentation, including: Process Flow Diagrams Control Plans Process Drawings Capability Studies Design Failure Mode and Effects Analysis (DFMEA) Process Failure Mode and Effects Analysis (PFMEA)

Support Supplier Process Qualification And Validation Activities, Including

• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Measurement System Analysis (MSA)
• Test Method Validation (TMV)

Additional Supplier Quality Activities

• Conduct supplier risk assessments, segmentation, and maintain supplier risk profiles.
• Establish and maintain Supplier Quality Agreements with external suppliers.
• Plan, coordinate, and perform supplier audits to ensure ongoing compliance.
• Support supplier selection and qualification activities for new products and engineering changes.
• Collaborate with Global Supplier Quality teams to implement Supplier Data Review (SDR) and Supplier Owned Quality (SOQ) initiatives.
• Route quality documentation through Product Lifecycle Management (PLM) systems and ensure timely approvals and document releases.
• Investigate supplier quality issues, identify root causes, implement corrective and preventive actions (CAPA), and drive continuous improvement initiatives.
• Monitor supplier performance through quality metrics, scorecards, and key performance indicators (KPIs).
• Partner with Engineering, Manufacturing, Regulatory, Operations, and Supply Chain teams to resolve supplier quality concerns.
• Support internal and external audits while ensuring compliance with applicable quality management systems.

Qualifications

• Bachelor's degree in Engineering, Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related technical/scientific discipline.
• Minimum 8+ years of Supplier Quality Engineering experience within the Medical Device industry.
• Strong understanding of FDA regulations, ISO 13485, and medical device quality systems.
• Hands‑on experience with supplier qualification, supplier development, and supplier quality management.
• Experience reviewing and approving PPAP documentation.

Summary

We are seeking an experienced Supplier Quality Engineer (SQE) to support supplier quality initiatives within the Medical Device industry. The ideal candidate will be responsible for ensuring suppliers consistently deliver high-quality materials, components, and services that comply with regulatory requirements and organizational quality standards. This role requires strong expertise in supplier quality management, process validation, risk assessment, PPAP, and quality systems.