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Medical Device QA Manager

Irvine, CA
  • Posted: 1 day ago
  • $120,000 to $150,000 Yearly
  • Full-Time
Job Description
Medical Device QA Manager
Location: Work remote with 10% travel
Skills: Currently a Quality Manager with several years in medical devices
Compensation: up to 150k base + 10% bonus and full benefits

Stellar opportunity to join an implantable cardiac medical device company at an early stage! If you are seeking a well funded startup and hence an opportunity to make a huge impact then keep reading.......
Top Reasons to Work with Us
- Pre IPO valuation at $800m! One of the best funded startups in the history of medtech.
- Great team culture. Work with people who love what they do.
- Opportunity to work on a unique product which is one of the most complex and sophisticated implantable medical devices and will save millions of lives.
- Excellent career advancement potential.
- Join a US startup owned by a highly successful company. Get the fun of a startup but with financial stability!
What You Will Be Doing
- Lead mentor and grow a small team of Quality Engineers
- Develop and implement the company's quality management systems
- Own ISO 13485 and FDA 21 CFT Part II compliance
- Ensure designs comply with quality management systems
- Assist with the preparation of documentation for FDA review
- Develop a risk based supplier management system
- Own the approved suppliers list and perform regular audits
What You Need for this Position
- 8+ years in Quality
- Strong experience with quality for medical devices (Class III ideal but NOT essential)
- IDE Submissions
- FDA Interaction
- Experience leading Quality teams
What's In It for You
- Medical, Dental, and Vision insurance through Blue Shield & Kaiser; both HMO/PPO options; company pays $480 per employee or $960 per employee + Family per month
- 10 paid holidays
- Annual bonus
So, if you are a Medical Device QA Manager with experience, please apply today!
Colorado employees will receive paid sick leave. For additional information about available benefits, please contact Sally Janavicius

Applicants must be authorized to work in the U.S.

CyberCoders, Inc is proud to be an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.



Irvine, CA



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