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About this job
Key facts
Senior Manager of Quality Assurance
Permanent
ASAP
No
Irvine, California, United States
US$150000 - US$175000 per annum US$
We are partnering with a venture-backed, commercial-stage medical device company developing next-generation vascular technologies designed to improve procedural efficiency and patient outcomes.
With recent funding secured to accelerate commercial expansion and clinical programs, the company is scaling rapidly and looking to bring on a hands-on Quality Assurance Leader to build and own quality across the organization.
About the Company
* Innovative portfolio focused on minimally invasive vascular / embolization technologies
* Disrupting a large, established market with legacy competitors through differentiated device design and performance
* Commercial-stage with FDA-cleared products and growing clinical adoption
* Backed by top-tier medtech investors and led by a team with multiple successful exits
* Strong trajectory toward rapid commercial scale-up and indication expansion
What You'll Be Doing
* Lead and own complaints, CAPA, audits, and QMS management
* Serve as the Voice of Quality across Regulatory, Engineering, and Operations
* Support product quality from design through post-market surveillance
* Lead and scale the Quality Assurance function (team, systems, processes)
* Drive quality strategy as the company expands commercially and clinically
What We're Looking For
* 7+ years of Medical Device Quality experience
* Experience with Class II and/or III devices
* Strong background in complaints, CAPA, audits, and QMS ownership
* Experience in a small-to-mid-size or scaling organization
* Expertise across design controls through post-market changes
* Prior leadership or mentorship experience
Why This Role?
* Join a company at an inflection point of growth and commercialization
* Work on innovative vascular technologies addressing unmet clinical needs
* Opportunity to build and shape the Quality function from the ground up
* High visibility with executives and direct impact on product success
* Culture built by leaders with a track record of building and exiting medtech companies
EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.
To find out more about Real, please visit www.realstaffing.com
