Senior Quality Engineer – Medical Devices || Arden Hills, MN (Onsite)

Senior Quality Engineer – Medical Devices

Arden Hills, MN (Onsite)

Phone + Video

Job Description:

Client is seeking a Service Quality Engineering Consultant to support Capital Equipment Service Quality initiatives, including new product development, sustaining activities, and Quality System changes.

 

This consultant will partner closely with Service Development Engineering, Product Teams, Quality, Service Support, and Customer Care to ensure capital equipment service activities are properly developed, documented, implemented, and maintained throughout the product lifecycle.

 

Key Responsibilities

 

Support Service Development Quality Engineering activities for new product launches and sustaining changes involving capital equipment

• Act as a Quality Engineering team member supporting assigned capital equipment products
• Review, author, update, and approve service-related quality documentation, including:
• Service Plans
• Service Work Instructions
• Service Checklists
• Service Risk Analyses
• Support product releases and sustaining changes by tracking and completing required Quality reviews, approvals, and deliverables
• Identify and support NCEPs, CAPAs, and other quality investigations related to noncompliance with internal procedures or external regulations
• Provide Quality guidance to Service Support and Customer Care teams
• Support Quality System changes and change management activities
• Participate in technical reviews and cross-functional discussions related to Capital Equipment Quality
• Review and update Quality System procedures, SOPs, and Work Instructions, including redlines and new drafts
• Support quality reviews and data evaluation related to service records and system accuracy

 

Required Background

• Approximately 5 years of medical device industry experience, preferably within Quality Engineering, Service Quality, or a closely related function
• Experience working within a medical device Quality organization as a Quality Engineer, QA Specialist, or similar role
• Hands-on experience with CAPA, NCEP/nonconformance processes, change control, and Quality System activities
• Experience authoring, reviewing, or approving Quality documentation and procedures
• Experience supporting capital equipment, particularly equipment requiring ongoing field service, maintenance, troubleshooting, or service documentation