Sr. Quality Engineer - Manufacturing
Job in
Valley City, Barnes County, North Dakota, 58072, USA
Listed on 2026-10-18
Listing for:
Tandem Diabetes Care, Inc.
Full Time
position Listed on 2026-10-18
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist -
Engineering
Quality Engineering, Regulatory Compliance Specialist, Process Engineer
Job Description & How to Apply Below
Senior Quality Engineer supporting manufacturing operations for insulin pump devices at a diabetes technology company. The role involves sterilization validation, cleanroom environmental control, process improvements, and quality system oversight to ensure regulatory compliance and product safety.
Responsibilities- Lead sterilization validation activities including dose establishment, audits, and compliance monitoring
- Oversee cleanroom environmental monitoring programs and investigate excursions or control deviations
- Review and approve product, process, and design changes for regulatory conformance
- Conduct quality investigations, root cause analyses, and support corrective/preventive actions
- Collaborate with cross-functional teams on process improvements and quality system enhancements
- Bachelor's degree in technical field, preferably Mechanical Engineering or equivalent
- 5+ years quality engineering experience in manufacturing environments
- Expertise in sterilization processes, bacterial endotoxin testing, and cleanroom operations
- Knowledge of ISO 11137, ISO 13485, ISO 14644, and FDA quality system regulations
- Experience with validation protocols, non-conformance investigation, and root cause analysis
- Proficiency in statistical analysis, process capability, design of experiments, and risk assessment
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