Quality System Analyst

Quality System Analyst

Company: Omega Plastics Inc

Primary Location: 24401 Capital Blvd, Clinton Township, MI 48036 USA

Workplace Type: On-site

Employment Type: Salaried | Full-Time

Function: Quality

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Main Duties & Responsibilities

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.

Qualifications

Qualifications:

• Bachelor's degree (minimum required), preferably in Engineering, Life Sciences, or related technical field
• Minimum three (3) years of experience in quality systems, document control, technical writing, or regulated manufacturing environment
• Working knowledge of 21 CFR Part 820 and ISO 13485 requirements
• Strong analytical skills with experience in data trending and quality metrics
• Proficiency in Microsoft Office (Word, Excel, Outlook) and database/QMS systems
• Excellent written and verbal communication skills
• Strong organizational skills, attention to detail, and ability to manage multiple priorities
• Self-motivated with demonstrated problem-solving ability

Benefits

Benefit offerings include Medical Insurance and Prescription Drugs, Dental Insurance, Vision Insurance, Flexible Spending Accounts, Life Insurance, Short-Term Disability, Long-Term Disability Insurance (for eligible employees), Employee Assistance Plan (EAP), Paid Time Off (may include vacation and sick time), Retirement Program, and Other Voluntary Benefits.

Click here for more information: www.trimasbenefits.com