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

Main Duties & Responsibilities

The SeniorQuality Assurance Manager is responsible for the strategic leadership,development, implementation, maintenance, and continuous improvement of theCompany's Quality Management System (QMS). This role ensures the QMS remainseffective, compliant, and aligned with applicable regulatory requirements,including FDA 21 CFR Part 820, ISO 13485:2016, customer requirements, and otherapplicable standards throughout the product lifecycle-from design anddevelopment through commercial manufacturing and post-market activities.

This positionprovides organizational leadership in quality and regulatory compliance byestablishing effective quality processes, driving continuous improvementinitiatives, identifying compliance risks, and implementing corrective andpreventive actions. The Senior Quality Assurance Manager partners with leadersacross all functional areas to foster a culture of quality, accountability, andcontinuous improvement while ensuring employees receive the training andguidance necessary to maintain compliance.

Serving as the Management Representative andlead for external quality audits, this role is responsible for coordinating andrepresenting the organization during customer, certification body, andregulatory audits. The Senior Quality Assurance Manager also providesleadership and oversight for the Quality Assurance Department, including directmanagement of Quality Assurance personnel and the Quality Control Manager,ensuring departmental objectives support the organization's quality andbusiness 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.