Quality Engineer Associate

Quality Engineer Associate

Company: Omega Plastics Inc

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

Employment Type: Hourly | Full-Time

Function: Quality

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Main Duties & Responsibilities

Position
Summary:

The Quality Engineering Associate is responsible for
NCR system management, calibration system coordinating, environmental
monitoring and trending, technical writing, training, DHR document preparation
and review, creating certificates of compliance/analysis, creating support
documentation as required, defect monitoring and trending, data Analysis,
document control backup, Quality Plan Development and maintenance, print review
and ballooning, and other duties as assigned by Director of Quality and
Regulatory.

Specific
Responsibilities:

Uphold and communicate the purpose, principles, and vision of Omega Plastics and TriMas
Perform and report on particulate measurements for cleanroom monitoring, conducting quarterly trend analysis to ensure compliance with cleanliness standards.
Maintain defect tracking and perform quarterly trend analysis to identify patterns and support corrective actions.
Oversee the Non-Conformance Reporting (NCR) system, ensuring non-conformances are logged, addressed, and resolved within quality requirements.
Manage the calibration system, ensuring equipment meets accuracy standards and records are kept up to date.
Prepare and approve Certificates of Compliance for product release, ensuring compliance with testing and customer requirements.
Conduct internal audits of the QMS to ensure ongoing compliance and identify areas for improvement.
Analyze quality and process data to support validation process, Gage R&R, identify trends, root causes, and improvement opportunities, supporting data-driven decision-making in quality processes.
Assist with document creation and revisions and provide retraining when non-compliance is identified.

Benefits

Medical Insurance and Prescription Drugs
Dental Insurance
Vision Insurance
Flexible Spending Accounts
Basic Life and AD&D Insurance
Voluntary Term Life and AD&D Insurance
Basic Short-Term Disability
Basic Long-Term Disability Insurance (for eligible employees)
Employee Assistance Plan (EAP)
Comprehensive Wellness Program
Voluntary Critical Illness and Accidental Injury Insurance
Paid Time Off (Includes vacation and sick time)
Retirement Program
Optional Life Insurance
Optional Long-Term Disability
Other Voluntary Benefits

Compensation:

$21.50 - $25.00/hourly depending on experience.

Please Visit Trimasbenefits.com for more information

Qualifications
Associate's degree at a minimum
Minimum of 3 years of experience in quality control, technical writing, document management or a related function.
Awareness and understanding of 21 CFR 820 and ISO13485
Strong time management, organizational, planning and self-motivation/proactive skills
Ability to complete different forms and prepare documents as well as maintain files
Excellent computer skills in Microsoft Office products, including Word, Excel, and database programs are required.
Must be well organized, have acute attention to detail and follow-through.
Excellent written communication skills and good
customer service skills.