IMPORTANT: for your application to be considered, youMUSTinclude an updated resume.
About Us:
Avive Solutions, Inc. ( is a VC-backed healthcare technology company that is developing a next-generation Automated External Defibrillator (AED) and response system in an effort to literally save lives. Sudden Cardiac Arrest (SCA) is a leading cause of death in the United States, and we are on a mission to change that! We are a dynamic team that builds elegant, creative solutions to solve complex problems. Ultimately, our mission is for all cardiac arrest victims to have rapid access to life-saving defibrillation.
Avive is taking a fresh approach to addressing this decades-old problem by working to bring an advanced AED technology to market, coupled with a first of its kind software platform solution to enable a quicker and more streamlined response to cardiac arrest emergencies. We believe that this unique combination of deploying advanced yet still accessible hardware, and novel software, has the potential to revolutionize out-of-hospital cardiac arrest response and massively impact SCA survival rates.
Check out this short video that shows a glimpse of how our team is working to re-think cardiac arrest response and save lives!
About the Role:
This position will be hybrid (on-site at our headquarters in the Bay Area at least 2-3 days/week with the remaining 2-3 days offering a flexible/remote location).
We are looking for a full-time Head of Quality Assurance that is excited to join a fast-growing startup and lead our growing Quality department. You will represent the Quality department at the senior management level, and be responsible for ensuring that we launch high-quality products (pre and post-market quality) and that the entire company operates in compliance with regulatory and international standards.
What You Will Do:
Own cradle to grave (pre- and post-market Quality) – from New Product Development to obsolescence, and generally the quality of all products in the business
Launch new products with high quality and ensure quick resolution to quality issues on launched products as well as work closely with several functions including Sales & Marketing, R&D/Product, Field Service, Operations, Project Management, and others
Establish and maintain Standard Operating Procedures and Forms related to areas of responsibility
Lead and/or participate in third-party and internal quality audits involving areas of responsibility; assist with related corrective/preventive action planning and implementation
Perform comprehensive document reviews to verify the completeness of Device Master Records and generates status reports; work with contract manufacturers to ensure the proper transfer of company requirements into the contractors Device Master Records
Ensure that product development, manufacturing and related functions are conducted in compliance with international standards and government regulations in support of the Company’s mission
Review regulatory compliance requirements for changes affecting device manufacturing in global markets. Support quality system changes to support evolving regulations and international standards
Serve as Management Representative, Management Review host, and primary QMS audit/inspection host. Champion Quality by providing visibility to executive leadership and the entire team
Manage and provide updates for quality metrics, and use a data-driven approach to implement appropriate improvements
Define targets, KPIs, and performance objectives for the Quality team and manage direct reports to meet or exceed these targets
Who You Are:
You have successfully led Quality in a demanding and rapidly-paced environment
You have developed and implemented efficient strategies for Quality, preferably in a dynamic, fast-growing entrepreneurial company
You have a demonstrated history of working effectively with peer groups in R&D (software/firmware, mechanical, electrical, systems) and Marketing to organize and strategize the development and launch of new products
You are a strong leader who can inspire people to take action and accept accountability; incite in them a sense of purpose and enthusiasm; instill trust and credibility within and among the teams; establish productive linkages across functional and departmental boundaries
You are an excellent problem-solver who recognizes new or improved ways of doing business, who shows initiative by recommending and implementing needed improvements, and who analyzes new opportunities efficiently and thoroughly
You have a successful track record of hiring, coaching, and developing Quality individuals
You either have a Masters degree with 10+ years of experience, or a BS/BA with 15+ years of experience in a quality assurance role with a clear upward career growth trajectory
You have extensive experience in an FDA and ISO regulated environment
(Preferred) You have at least ten years of experience in manufacturing operation quality leadership, preferably in a medical device company manufacturing high-volume products
Associated topics: automation, performance test, process, prevent, prevention, qa, quality, quality assurance engineer, test engineer, tester