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.