Quality Systems Manager

How You’ll Contribute Lead and continuously improve the Quality Management System (QMS) to ensure compliance with regulatory requirements, quality standards, and company objectives while fostering a culture of quality and operational excellence. What You’ll Do Lead the implementation, maintenance, and continuous improvement of the QMS across the organization.

Oversee key quality system functions, including document control, CAPA, internal audits, training, and management reviews. Drive quality and compliance initiatives by partnering with cross-functional teams to improve processes and regulatory readiness. Manage external audits and inspections, including preparation, execution, responses, and follow-up activities.

Partner with cross-functional departments to drive quality system effectiveness and ensure consistent execution of quality processes and procedures. Develop, coach, and support quality team members while monitoring quality system performance metrics and continuous improvement efforts. How You’ll Get There Required Qualifications Bachelor’s degree and 8+ years of experience in Quality Assurance, Quality Systems, or related medical device quality functions.

Minimum 1 year of people leadership, supervisory, or management experience. Strong knowledge of FDA Quality System Regulation (QSR), ISO 13485, and applicable medical device quality requirements. Experience managing audits, CAPA programs, document control, and Quality Management System activities in a regulated environment.

Experience leading cross-functional projects and driving quality system improvements. Ability to analyze quality metrics and translate findings into actionable improvements. Strong written, verbal, organizational, and leadership skills. Quality certifications (ASQ CQE, CQA, or equivalent) preferred. This role is based onsite in Aliso Viejo, CA or Burlington, MA.