Service Quality Engineer

Redbock - an NES Fircroft company; Arden Hills (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Redbock - an NES Fircroft company in Arden Hills, MN seeks a Service Quality Engineering Consultant to support Capital Equipment Service Quality initiatives across new product development, sustaining changes, and Quality System updates, focusing on CAPA and nonconformance management.

The consultant will partner closely with Service Development Engineering, Product Teams, Quality, Service Support, and Customer Care to ensure service quality activities are properly developed, documented,

Qualifications

• Approximately 5 years of medical device industry experience in Quality Engineering, Service Quality, or related field.
• Experience authoring, reviewing, or approving Quality documentation and procedures.
• Hands-on experience with CAPA, nonconformance, and quality system activities.

Responsibilities

• Support Service Development Quality Engineering activities for capital equipment products.
• Review, author, update, and approve service-related quality documentation (Service Plans, Work Instructions, Checklists).
• Support product releases and sustaining changes by coordinating Quality reviews and deliverables.
• Identify and support CAPAs, NCEPs, and other quality investigations.
• Provide Quality guidance to Service Support and Customer Care teams.
• Participate in Quality System change management and cross-functional reviews.
• Review and update Quality System procedures and SOPs.

Skills

Quality engineering

CAPA

Change control

Documentation

Cross-functional collaboration

Job description

A large medical device company in Arden Hills, MN 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
• 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