Job Information
TriMas Corporation Quality System Analyst in Clinton Township, Michigan
Position Summary:
The Quality Systems Analyst is responsible for administration and continuous improvement of key Quality Management System (QMS) processes including Nonconforming Product (NCP), calibration management, environmental monitoring, document control, defect trending, DHR review, and product release documentation.
This role supports compliance with 21 CFR Part 820, ISO 13485, and customer-specific requirements through data analysis, internal auditing, technical documentation, and cross-functional quality support activities.
Job Responsibilities:
Calibration System Compliance and Effectiveness
Defect & Environmental Monitoring and Trend Reporting
Certificate of Conformance/Analysis Review and Approval for Product Release
Promote and uphold the mission, values, and quality objectives of Omega Plastics and TriMas
Manage product-related document control, ensuring revision accuracy and regulatory compliance
Oversee the Nonconforming Product (NCP) system, ensuring timely documentation, investigation, and closure
Manage the calibration system, ensuring equipment accuracy, traceability, and compliance with internal and customer requirements
Perform and trend cleanroom environmental monitoring, including particulate analysis, and report findings to leadership
Maintain defect tracking systems and conduct periodic trend analysis to identify recurring issues and drive corrective actions
Prepare, review, and approve Certificates of Conformance/Analysis in accordance with customer specifications
Prepare and review Device History Records (DHRs), ensuring completeness and adherence to Good Documentation
Practices (GDP) prior to product release
Conduct internal audits of QMS processes and support external audits as required
Analyze quality and process data to support validation activities, Gage R&R studies, and process capability assessments
Assist with technical writing, SOP revisions, quality plan development, and training documentation
Provide retraining when documentation or procedural non-compliance is identified
As needed, review engineering prints and balloon critical specifications to support inspection planning and production controls
Support software validation, quality data trending, and other quality assurance initiatives as assigned
Participate in Internal Audits and continuous improvement initiatives to strengthen QMS effectiveness
Other Duties as assigned to support quality assurance such as software package validation and QC data trending
This role is required to be on-site 5 days at the Clinton Township, MI location.