A Quality Assurance Manager focuses on prevention of mistakes and defects in manufacturing products. Develops procedures to ensure that quality standards are maintained. Manages all steps related to quality assurance as part of the quality management strategy of a company. May involve leadership of a team of quality assurance supervisors, specialists, and other associated staff members.
Sr. Quality Assurance Manager TriMas Corporation medical insurance, dental insurance, life insurance, vision insurance, paid time off, sick time United States, Michigan, Clinton Township 24401 Capital Boulevard (Show on map) Jul 28, 2026 Sr.
Quality Assurance Manager 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 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.
