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Full-time
bachelor degree
Medical Insurance, Prescription Drugs, Dental Insurance, Vision Insurance, Flexible Spending Accounts, Life Insurance
Posted 26d ago
~40 hrs/week
Responsibilities
The Senior Quality Assurance Manager leads the development and maintenance of the Quality Management System to ensure compliance with FDA and ISO standards. They also manage the Quality Assurance department and represent the organization during external regulatory and customer audits.
Requirements
Candidates must have a bachelor's degree in a technical discipline and at least 8 years of experience in a regulated ISO 13485 plastic injection manufacturing environment. Additionally, 5 years of leadership experience in a quality team is required.
Full job description
Sr. Quality Assurance Manager
Company: Omega Plastics Inc
Primary Location: 24401 Capital Blvd, Clinton Township, MI 48036 USA
The Senior
Quality Assurance Manager is responsible for the strategic leadership,
development, implementation, maintenance, and continuous improvement of the
Company's Quality Management System (QMS). This role ensures the QMS remains
effective, compliant, and aligned with applicable regulatory requirements,
including FDA 21 CFR Part 820, ISO 13485:2016, customer requirements, and other
applicable standards throughout the product lifecycle—from design and
development through commercial manufacturing and post-market activities.
This position
provides organizational leadership in quality and regulatory compliance by
establishing effective quality processes, driving continuous improvement
initiatives, identifying compliance risks, and implementing corrective and
preventive actions. The Senior Quality Assurance Manager partners with leaders
across all functional areas to foster a culture of quality, accountability, and
continuous improvement while ensuring employees receive the training and
guidance necessary to maintain compliance.
Serving as the Management Representative and
lead for external quality audits, this role is responsible for coordinating and
representing the organization during customer, certification body, and
regulatory audits. The Senior Quality Assurance Manager also provides
leadership and oversight for the Quality Assurance Department, including direct
management of Quality Assurance personnel and the Quality Control Manager,
ensuring departmental objectives support the organization's quality and
business goals.
This role is required to be on-site 5 days a week at the Clinton Township, Michigan location.
Qualifications
Bachelor’s degree in a technical discipline or equivalent experience.
8+ years experience with FDA 21 CFR Part 820, ISO 13485, ITAR, CAPA, audits, validation, and Quality Management Systems.
8+ years of progressive Quality Assurance experience in a regulated ISO13485 plastic injection manufacturing environment.
5+ years experience in a leadership role for a quality team
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.
Only US Manufacturer of High-Pressure Steel & Acetylene Cylinders
Industry
Packaging and Containers Manufacturing
Company size
201-500 employees
Headquarters
Longview, Texas
LinkedIn followers
1,846
Norris Cylinder Company (a division of TriMas Corporation) manufactures quality high-pressure steel and acetylene cylinders. We are the only steel cylinder manufacturer in North America and serve our domestic and international customer base from two state-of-the-art manufacturing locations in Longview, Texas and Huntsville, Alabama. With more than 70 years of cylinder manufacturing know-how and a production capacity that serves customers in more than 80 countries worldwide, Norris Cylinder leads the industry in customer satisfaction through its dedication to quality, customer service excellence and technical expertise. Our wide range of cylinder products are used throughout many industries including industrial gases, specialty gases, fire suppression, breathing air, aviation, aerospace, and many more.
Offices: 4818 W. Loop 281, Longview, Texas 75603, US · 521 Green Cove Road, Huntsville, Alabama 35803, US
Industrial Gas Cylinderssteel cylindersspecialty cylindersand Made in USAConsumer GoodsManufacturing
Based on 1873 listings with disclosed salaries, most engineering jobs in Michigan pay between $75k–$184k per year. Individual offers vary with seniority, company size, and specialization.
How many Engineering jobs are open in Michigan right now?
There are currently 7,889 open engineering positions in Michigan listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in Michigan?
Companies currently hiring include Ford Motor Company, Stellantis, General Motors, Flex-N-Gate, Magna International, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Engineering jobs in Michigan?
Yes — 1851 of the 7889 open engineering positions offer remote or hybrid work (289 remote, 1562 hybrid).
How do I apply for Engineering jobs in Michigan?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.