Senior Medical Device Quality Engineer​/Quality Manager

We are seeking a Senior Medical Device Quality Engineer / Quality Manager to join our Irvine, CA team. This is a hybrid role combining Quality Management System (QMS) leadership with hands-on product and process quality engineering responsibilities.

The ideal candidate will ensure the effectiveness, compliance, and audit readiness of the Quality Management System
, while also partnering with R&D, manufacturing, and suppliers to ensure product quality, process capability, and regulatory compliance throughout the product lifecycle.

• Develop, implement, maintain, and continuously improve the Quality Management System
• Ensure compliance with applicable regulations and standards, including:
• FDA 21 CFR Part 820 (QSR)
• ISO 13485
• ISO 9001 (as applicable)
• Lead and support internal and external audits
  , including FDA inspections and Notified Body audits
• Own document control
  , including SOPs, work instructions, and quality records
• Manage CAPA, change control, management review
  , and quality metrics
• Train personnel on quality system requirements and regulatory expectations

• Ensure products and processes meet defined quality, regulatory, and customer requirements
• Support design controls
  , including design verification, validation, and change management across the product lifecycle
• Define and maintain:
• Inspection and test methods
• Quality control plans
• FMEA and risk management (ISO 14971)
• Support New Product Introduction (NPI) activities
• Analyze product and process issues using root cause analysis tools (e.g., 8D, Fishbone, 5 Why)
• Apply statistical quality tools such as SPC, Cp/Cpk
• Oversee raw material quality evaluation, supplier quality activities, and product shelf-life verification
• Review and audit product quality activities completed by other team members

• Bachelor’s degree in Engineering or Science
• 3–5+ years of experience in medical device quality or quality assurance
• Strong working knowledge of:
• FDA QSR / 21 CFR Part 820
• ISO 13485
• Medical device design controls and risk management
• Experience supporting or leading internal and external audits (FDA, Notified Bodies, ISO)
• Strong written and verbal communication skills

• Degree in Mechanical Engineering, Materials Science, or Polymer Science
• Experience with catheter-based or implantable medical devices
• Proficiency with Solid Works or CAD tools
• Previous experience in a startup or fast-growing medical device environment

• Opportunity to contribute to life-saving vascular technologies
• Exposure to global regulatory environments
• Fast-growing organization with career growth potential
• Collaborative, technically strong engineering and quality teams