Quality System Analyst

Quality System Analyst Clinton Township, MI Job Details Full-time 1 day ago Benefits Disability insurance Health insurance Dental insurance Flexible spending account Paid time off Employee assistance program Vision insurance Life insurance Qualifications Quality control corrective actions Record keeping Document review (document control) Microsoft Excel Microsoft Outlook Procedural guides Calibration Technical documentation ISO standards Engineering Regulatory compliance Data analysis skills Compliance audits & assessments Data reporting Mid-level 3 years Databases Analysis skills Bachelor's degree in engineering Bachelor's degree Quality control documentation Organizational skills Technical writing Cleanroom Continuous quality improvement (CQI) Quality audits Quality assurance within manufacturing Manufacturing Cross-functional collaboration Manufacturing company experience Communication skills Technical Proficiency Regulatory compliance management FDA regulations Engineering validation

Full Job Description 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.

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