Role: Service Quality Engineer
Location: Arden Hills, MN (Onsite)
Duration: 12+Months
Pay Rate: $48-52/hr on W2
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
Examples of capital equipment category: RF generators
Synergy Gen 3 endoscope camera/imaging system
AU chemistry analyzers
Phadia immunochemistry systems
CellaVision automated cell analysis systems
Flowmet diagnostic device, depending on the specific configuration and purchasing model
Salary
The hourly rate for this position is $48 $52/hr on W2, depending on experience and qualifications.
Benefits
Eligible employees may have access to benefits offered by Novozen Healthcare LLC in accordance with the applicable benefit plans and eligibility requirements.
Equal Employment Opportunity
Novozen Healthcare LLC is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.
Background Check
Background checks may be conducted in accordance with applicable law.