*Livongo is continuing to hire for all open roles with interviewing and on-boarding virtual due to COVID-19. Everyone new to the team, along with our current staff, will temporarily work from home until it is safe to return to our offices.
Create new paradigms for medical product regulatory compliance, as you join Livongo’s mission to take medical care platforms to a new, digital level. This cutting-edge Manager, Quality role breaks the standard mold, giving you the chance to apply ingenuity and innovation, along with development expertise.
In your role as Manager, Quality serve as leader of the group that works cross-functionally with our Product Development, Design, Marketing, Supply Chain and Customer Support teams on a diverse medical product portfolio, exploring exciting new fields such as mobile medical apps, machine learning, in-vitro diagnostic devices, and Software as a Medical Device (SaMD). Approaching compliance in ways no one else does, you’ll employ quality principles and Livongo procedures to ensure compliance with FDA regulations during development of hardware and software-based products.
Other companies have medical devices. We have a whole eco-system of digital, interactive, patient-focused chronic care platforms. This is your chance to step outside the box and break tradition. If you’re a medical product developer with a boundary-pushing mind-set, our VP, Quality Assurance & Regulatory Affairs would love to talk to you.
- Lead and manage QM and QA team and assist with the design, development, and commercialization (full product life cycle) of electro-mechanical, digital health and/or diagnostic devices
- Provide QM and QA support during development of new product designs and production processes, proving FDA compliance in new and different ways
- Manage Livongo product design with respect to the following principles: design control, change control, risk management, human factor engineering, process validation, and supplier management
- Work closely with Product and Technology teams to create and execute on design development plans, risk management plans, V&V plans, product test cases, trace matrices, labeling,
- Work with Livongo’s Technology team to continuously streamline the design development processes
- Manage risk analysis for both new design and product/process changes
- Elevate Livongo’s compliance to ISO 14971 and ISO62304, as well as internal Livongo QSPs, providing product QA leadership
- Review and provide feedback on project decisions and deliverables
- Provide Quality and compliance input for post-market activities, such as hardware changes and software updates, review of customer complaints, and CAPAs
- Partner with department and project leaders in developing and reporting appropriate performance and Quality metrics
- Ensure that design and process changes made with our suppliers are vetted for potential product performance impact
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving Quality issues
- Support internal and external audits
- Travel domestically or internationally 2-3 times per year
Our successful candidate will have:
- 10+ years of Quality or Engineering experience in the medical device industry
- Experience leading a Quality or Engineering team in the medical device industry
- Experience with Quality Management Systems including: 21 CFR 820 and ISO 13485
- Demonstrated experience with IEC 62304, ISO 14971, and IEC 62366
- A Bachelor of Science in an Engineering discipline, preferably Software, Mechanical, Electrical or Biomedical Engineering
- Experience interacting with Notified Bodies and regulatory agencies, especially the FDA
- Experience in both hardware and software development
- Passion for finding new, innovative, non-traditional methods for accomplishing goal
- Knowledge of medical device design controls
- The ability to work in a cross-functional team environment, building rapport and influencing decisions across all levels of the organization
- Excellent written, verbal and presentation skills, including the ability to communicate clearly, succinctly, and effectively, remotely and in writing
- The drive to meet deadlines and achieve or exceed goals and expectations
- The ability to strictly follow policies and procedures when required, while also knowing when to think outside the box
- The flexibility to adapt to changing work environments, new priorities, new instructions, delays, or unexpected events
- Skill at managing competing demands, with the ability to change approach or method to best fit the situation
Why Join Livongo?
The Transformative Name in Healthcare: The transformative industry forces in Community, Content and Commerce are now household names. As Amazon is to Commerce, Livongo is to Healthcare. With our Applied Health Signals engine, AI+AI, we’ve transformed how care is delivered.
Our Work Truly Matters: Livongo’s proprietary, consumer-first technology is revolutionizing the experience of living with a chronic health condition. Our data-driven digital health engine enables our Members to seamlessly manage multiple health conditions on one empowering platform. We use smart, connected devices, personalized digital guidance, and 24x7x365 access to health professionals to make it easier for people to stay healthier.
Make an Impact: Do you want to accomplish something meaningful? To create results that matter. Livongo’s innovative solution produces industry-leading member satisfaction, measurable clinical outcomes and proven healthcare costs savings. Here you can truly improve lives.
The Largest Digital Health IPO in History: We are at a milestone period in our history. On July 25, 2019 we took our company public, in order to elevate and expand the way the industry views us, thus ushering us into a whole new set of mission-critical conversations that will help us accomplish the work still to be done. As we reach new levels of achievement, we accelerate our ability to deliver life-changing services.
Focus on PEOPLE: Livongo has been voted one of the Best Places to Work in healthcare, by Fortune Magazine and Best Place to Work! Talented, passionate individuals make the difference, in this fast-moving, collaborative and inspiring environment.
Diversity and Inclusion: At Livongo we believe that personal and professional diversity is the key to innovation. We hire based solely on your strengths and qualifications, and the way in which those strengths can directly contribute to your success in your new position.
Growth and Innovation: We’ve already made healthcare history, yet we remain on the threshold of very big things. Leading the industry with our Applied Health Signals category, we have cracked the code to transforming healthcare. Come grow with us and support our mission to make a tangible difference in the lives of our Members.
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As an Equal Opportunity Employer, we never have and never will discriminate against any job candidate or employee due to age, race, religion, color, ethnicity, national origin, gender, gender identity/expression, sexual orientation, membership in an employee organization, medical condition, family history, genetic information, veteran status, marital status, parental status or pregnancy (including breastfeeding – we have a mother’s room in both our offices). In our innovative and inclusive workplace, we prohibit discrimination and harassment of any kind.