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.