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.

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.