Sr. Quality Assurance Manager

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.