Supplier Quality Engineer

Agiliti•Minneapolis, MN

1d•$65,269 - $169,743•Hybrid

About The Position

The Supplier Quality Engineer develops, implements, and maintains supplier quality management practices that meet Agiliti, customer, and regulatory requirements. This role partners cross‑functionally with quality, engineering, and suppliers to support product development, ensure compliance, and drive continuous improvement across the supply base.

Requirements

Bachelor’s degree in Engineering or Life Sciences.
Minimum of three (3) years of experience in Quality Engineering, including participation in IQ, OQ, PQ, and process validation activities.
At least two (2) years of experience in supplier quality management and supporting new product development projects.
Experience working within an ISO 13485‑compliant Quality Management System and medical device manufacturing environment.
Working knowledge of FDA 21 CFR Part 820 and ISO 13485 requirements.
Prior experience auditing suppliers and managing Supplier Corrective and Preventive Actions (SCAPAs).
Comprehensive understanding of quality system requirements under 21 CFR Part 820 and ISO 13485.
Strong analytical and problem‑solving skills, including application of basic statistical techniques.
Proficiency in Microsoft Office applications.
Excellent technical writing, verbal communication, and presentation skills.
Strong project management and facilitation abilities.
High attention to detail with the ability to work independently and manage multiple priorities.
Demonstrated ability to build effective cross‑functional partnerships internally and with suppliers.

Responsibilities

Participate in Quality Management System (QMS) activities including document control, records management, training and competency, nonconforming material reports (NCMRs), and corrective and preventive actions (CAPAs).
Lead supplier qualification, selection, and approval processes to ensure compliance with internal and external requirements.
Collaborate with quality and engineering teams throughout product development, including supplier new product qualification, validation, and process validation activities.
Apply structured problem‑solving methodologies to identify, prioritize, communicate, and resolve supplier quality issues.
Monitor supplier performance by collecting, analyzing, and reporting predefined quality metrics.
Ensure supplier containment actions and corrective measures meet Agiliti quality and regulatory standards.
Create and manage project schedules, deliver milestones, and support continuous improvement initiatives.
Conduct supplier quality audits and travel as needed to support issue resolution and compliance activities.