Our mission is to empower people to take control of their health with pioneering science, intuitive devices, and compassionate analysts. Our vision is a healthier, happier world where everyone understands their wellness condition and feels empowered to act upon it.
Responsibilities:
- Lead the Quality function for Invoy and develop it as the company scales up
- Lead the development of quality systems, including policies, processes and procedures
- Lead the adoption of eQMS tools and no-paper technologies
- Ensure manufacturing activities and product testing are appropriate, are conducted in compliance with company policies and procedures, and that there is supporting documentation
- Provide leadership for quality audits as well as corrective and preventive action (CAPA) plans for compliance issues and/or observations
- Support planning, scheduling and performing audits/inspections (internal and external) to assure adherence to company SOPs and any applicable regulatory requirements
- Propose and develop the Quality organization in line with the growth of the company
- Work in close partnership with the engineering and supply chain partners in order to build and execute the Operation’s strategy
Desired Characteristics:
- Bachelor’s Degree in Engineering required
- Proven experience leading and improving a QMS
- Experience and exposition to notified bodies or similar regulating bodies
- Experience managing contract manufacturer and supplier quality in general
- Experience in electronics box building and automation a big plus
- Experience managing project and project portfolio a big plus
- Ability to both work at the strategic level and the tactical level, hands on and can-do attitude
- 8+ years in the medical device industry, or similar regulated industry, with extensive experience in the quality department
- Experience leading an ISO 13485 audit
About Invoy
Invoy was founded to empower individuals to take control of their health at home. Invoy gives people the tools, the data and the support structure to be healthy. For too long weight loss has been plagued by loosely formed hypotheses with little underlying proof. Invoy has a goal of disrupting an industry that impacts hundreds of millions of lives.
Invoy uses breath chemistry to customize your wellness program. Invoy’s system is designed to make changes when your preferences change or your body has adapted to a program that was once effective for you. Your exhaled breath contains hundreds of chemicals that are released from your blood through your lungs. Fat metabolism is one of those items that can be measured and with its device the Invoy system is able to measure chemicals in your breath to determine if you are burning fat. Invoy’s team of dedicated analysts review your data every day to provide timely recommendations on how to achieve your goals. The Invoy system generates data-driven, personalized recommendations to help you reach your weight loss goal.
Invoy is a well-funded private company backed by top-tier venture capital firms known for their successes in the medical technology industry.