Supplier Quality Engineer

Katalyst-Healthcares-; Arden Hills (MN); On-site; USD 95,000 - 140,000; Full time

Job summary

Katalyst-Healthcares in Arden Hills, MN seeks a Supplier Quality Engineer to ensure suppliers deliver high-quality materials meeting medical device standards and regulatory requirements. You will manage supplier qualification, audits, risk assessments, and cross-functional collaboration across global teams.

Responsibilities include PPAP reviews, DFMEA/PFMEA, ASL management, CAPA, and continuous improvement to enhance supplier quality and product reliability across the supply chain.

Qualifications

• Bachelor's degree in engineering or scientific field.
• Minimum 8 years in supplier quality within medical devices.
• Strong knowledge of medical device QMS and regulatory requirements.
• Hands-on supplier qualification, audits, and ASL management.

Responsibilities

• Evaluate, qualify, and onboard new suppliers into the Approved Supplier List (ASL).
• Review PPAP documentation and related quality records (CPK/DFMEA/PFMEA).
• Perform supplier risk segmentation and mitigation planning.
• Coordinate supplier evaluations for new or changed components/processes.
• Support IQ/OQ/PQ and validation activities across teams.
• Collaborate with Global Supplier Quality and drive CAPA actions.

Skills

Supplier Quality

Risk Management

Audits

PPAP

CAPA

QMS Knowledge

Education

Bachelor's degree in engineering

Tools

PLM systems

ASL management

IQ/OQ/PQ processes

Job description

Job Summary

The Supplier Quality Engineer is responsible for ensuring that suppliers consistently deliver high-quality materials, components, and services that meet Healthcare's quality standards, regulatory requirements, and organizational procedures within the medical device industry. This role involves supplier qualification and onboarding, risk assessment, supplier audits, PPAP reviews, process validation, and continuous improvement initiatives. The position works closely with cross-functional and global teams to maintain supplier compliance, mitigate quality risks, and support product quality and reliability throughout the supply chain.

Roles and Responsibilities

• Ensure suppliers consistently deliver materials, components, and services that meet Healthcare's quality and regulatory requirements.
• Evaluate, qualify, and onboard new suppliers into the Approved Supplier List (ASL).
• Conduct product- and feature-level quality impact assessments and maintain supporting documentation.
• Review and approve Production Part Approval Process (PPAP) documentation, including Control Plans, Process Flow Charts, Process Drawings, Capability Studies, Design Failure Mode and Effects Analysis (DFMEA), and Process Failure Mode and Effects Analysis (PFMEA).
• Perform supplier risk segmentation, maintain supplier risk profiles, and implement appropriate risk mitigation strategies.
• Facilitate Supplier Quality Agreements and conduct supplier quality audits to ensure compliance with applicable quality system and regulatory requirements.
• Coordinate supplier evaluation and selection activities for new suppliers and changes to existing products, components, or manufacturing processes.
• Support and approve process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Review and support Measurement System Analysis (MSA), Test Method Validation (TMV), and Control Plan development and implementation.
• Route quality documentation through Product Lifecycle Management (PLM) systems, track approval workflows, and ensure timely document release.
• Collaborate with Global Supplier Quality teams to implement Supplier Data Review (SDR) and Supplier Owned Quality (SOQ) initiatives.
• Partner with cross-functional teams to resolve supplier quality issues, drive corrective and preventive actions, and support continuous improvement.
• Maintain accurate supplier quality records and ensure compliance with applicable medical device quality standards, regulatory requirements, and internal procedures.

Education and Experience

• Bachelor's degree in engineering, technical discipline, or a scientific field.
• Minimum of 8 years of experience in Supplier Quality Engineering or a related quality role within the medical device industry.
• Strong knowledge of medical device quality management systems, regulatory requirements, and supplier quality processes.
• Hands-on experience with supplier qualification, supplier audits, risk assessments, and Approved Supplier List (ASL) management.