Quality Engineer II
Job in
Dexter, Washtenaw County, Michigan, 48130, USA
Listed on 2026-06-02
Listing for:
Artech LLC
Full Time
position Listed on 2026-06-02
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Process Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Job Title:
Quality Engineer II
Location: Dexter, MI (Onsite)
Duration: 12 Months
Job : 24930
Pay: $40–$50/hr
Quality Engineer supporting MDR remediation and manufacturing quality for medical device products, focusing on process validation, risk management, and change control.
Top Skills (Must Have)- Process Validation (IQ, OQ, PQ)
- Validation lifecycle (process characterization → PQ)
- Test method validation & documentation
- PFMEA, Control Plans, risk documentation
- FAI, dimensional inspection, manufacturing change evaluation
- DOE experience (Minitab preferred)
- Execute process & test method validations (IQ/OQ/PQ)
- Perform First Article Inspections (FAI) and reporting
- Develop PFMEA, Control Plans, risk assessments
- Support MDR remediation activities
- Conduct packaging/fit testing and validation
- Review and approve change orders (Agile PLM)
- Perform label verification and production support
- Collaborate with manufacturing, engineering, warehouse teams
- CSV (Computer System Validation)
- SOP development
- Inspection sampling plans
- Packaging validation
- Change control (medical devices)
- 2+ years Quality/Validation experience
- Medical device experience preferred (MDR a plus)
- Bachelor’s in Engineering (Quality/Mechanical/Biomedical/Industrial)
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×