Title : Service Quality Engineer
Location: Arden Hills, MN (Hybrid Minimum 3 Days Onsite per Week)
Employment Type: Contract W2
Duration: 12+ Months, with potential extension
About the Role
We are seeking a Service Quality Engineer to support service quality initiatives for medical device capital equipment across new product development, product launches, sustaining activities, and Quality System changes. This role will collaborate with engineering, quality, service support, and customer care teams to ensure service processes and documentation meet applicable quality requirements.
Key Responsibilities
- Support Service Quality Engineering activities for new product launches and sustaining changes involving capital equipment.
- Author, review, update, and approve service quality documentation, including Service Plans, Work Instructions, Checklists, and Service Risk Analyses.
- Track quality reviews, approvals, and deliverables supporting product releases and sustaining changes.
- Support NCEP, CAPA, nonconformance investigations, and other quality-related activities.
- Provide quality guidance to Service Support and Customer Care teams.
- Support Quality System changes, change control, and procedure updates.
- Review and revise SOPs, work instructions, and other controlled quality documents.
- Evaluate service records and support data accuracy and quality reviews.
- Participate in technical reviews and cross-functional discussions related to capital equipment quality.
Required Qualifications
- Approximately 5 years of experience in the medical device industry.
- Experience in Quality Engineering, Quality Assurance, Service Quality, or a related quality function.
- Hands-on experience with CAPA, nonconformance/NCEP processes, change control, and Quality System activities.
- Experience authoring, reviewing, or approving quality documentation and procedures.
- Strong documentation, investigation, analytical, and cross-functional collaboration skills.
- Ability to work onsite in Arden Hills, MN at least 3 days per week.
Preferred Qualifications
- Experience supporting medical device capital equipment requiring field service, maintenance, troubleshooting, or service documentation.
- Familiarity with service quality activities across new product development and sustaining engineering.
- Experience with capital equipment such as RF generators, endoscope camera and imaging systems, chemistry analyzers, immunochemistry systems, or automated cell analysis systems.
Salary
The hourly rate for this position is $48 $52/hr on W2, depending on experience and qualifications.
Benefits:
This is a contract position and does not include employer-provided benefits.
Equal Opportunity Employer:
We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Background Check:
Background checks may be conducted in accordance with applicable law.
Work Authorization:
Applicants must be authorized to work in the United States.