Quality Assurance Manager

Quality Assurance Manager

We are proud to partner with a California-based medical device manufacturer dedicated to helping healthcare professionals clear patient airways. For over four decades, this family-owned business has prioritized airway management above all else, producing high-quality products that serve the medical community nationwide

Location:

Simi Valley, CA
Pay: $110k - $125k DOE

Hours:

Monday - Friday 8:00 AM - 4:30 PM

As the Quality Assurance Manager, you will be the architect and guardian of our Quality Management System (QMS). You won't just be sitting behind a desk; you'll work cross-functionally with every department to streamline production efficiency while ensuring every product meets rigorous regulatory standards. You are the internal expert who identifies gaps, offers strategic guidance, and ensures our legacy of excellence continues.

Responsibilities

Your role encompasses the full spectrum of quality oversight, from regulatory compliance to team leadership:

• Regulatory & Audits:
  Lead all internal and external audits; manage FDA-regulated recall files from initiation to closure; handle reportable event submissions and license renewals.
• QMS Maintenance:
  Oversee the Document Change Order (DCO) process, maintain Device Master Records (DMR), and conduct Post Market Surveillance (PMS) and Gap Assessments.
• Compliance & Safety:
  Ensure all products meet strict safety standards; manage CAPA (Corrective and Preventive Action) systems and the complaint handling process.
• Operations Support:
  Manage the calibration and preventive maintenance systems for equipment; oversee DHR (Device History Record) reviews and incoming inspection records.
• Data & Strategy:
  Prepare Management Review presentations by analyzing quality metrics and trends to drive continuous improvement.
• Leadership:
  Directly supervise the Quality Coordinator and Repair Clerk; manage personnel training records and identify professional development opportunities for the team.

Requirements and Qualifications

• Expertise:
  Deep familiarity with medical device regulatory requirements (FDA/ISO).
• Organizational
  
  Skills:
  
  Proven ability to manage complex documentation, meet firm deadlines, and coordinate vendor/supplier audits.
• Communication:
  Fluent in English with the ability to collaborate effectively across all levels of the organization.
• Mindset: A professional, solution-oriented "team player" who can work autonomously and thrives in a fast-paced environment.
• Interpersonal: A customer-centric attitude with a focus on "delighting" the end user through quality excellence.

Benefits:
We value our employees' health and long-term security. Our comprehensive package includes:

• Medical, Dental, and Vision Coverage
• Pharmacy Benefits
• Life Insurance & Long-Term Disability
• Paid Time Off (PTO)

Compensation / Pay Rate (Up to): $ - $ Per Year