- Bachelor’s degree in engineering, technology, science field or equivalent practical experience.
- 10 years of experience in quality assurance and regulatory compliance in the medical device industry including software as medical device.
- Experience with QMS models including ISO 13485, FDA’s Quality System Regulation.
- Experience participating in and leading regulatory audits.
- Master’s degree in engineering, technology, or science related field.
- Formal training or experience as a QMS auditor, and experience with regulatory agencies (e.g. FDA and notified bodies).
- Experience with Consumer Products/Applications, digital health, Health IT or mobile medical applications.
- Knowledge of all applicable regulatory requirements and harmonized standards internationally.
- Ability to work collaboratively with software development teams, link technical and systems strategies into the overall business strategy for the company, and manage both internal and outsourced technical resources.
About the job
At Google we’re committed to improving the lives of as many people as possible. One of the most important areas in which we’re striving to do that is health.
As a Quality Manager responsible for major portions of our Quality Management System (QMS), you will work closely with the Head of Quality to plan, develop and implement the QMS for Google Health including maintaining and improving the system and managing the impact Quality has on other Google teams. You will be responsible for the development, implementation, and maintenance of significant portions of the QMS and related programs, including supporting various activities in the implementation and continual improvement of the QMS in compliance with all corporate business requirements, regulations and other standards.
- Architect and advise on the QMS structure, content, philosophy and operation, by identifying process breakdowns, defining a QMS program/process to address complex problems and implement solutions that improve effectiveness.
- Drive and own the strategic QMS program/systems to ensure that quality assurance and regulatory compliance programs meet regulations and standards, including ongoing review and approval of QMS execution, proposed changes to policies and procedure, and periodic audits.
- Serve as the primary point of contact to external service providers executing quality assurance and regulatory compliance activities, external customer meetings and regulatory audits.
- Ensure sustained compliance, identify training and resource gaps and lead all QMS related functions.
- Serve as the Management Representative to the Management Review Team and advocate for the QMS system to the various cross functional organizations within Google or externally.
Google is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also Google’s EEO Policy and EEO is the Law. If you have a disability or special need that requires accommodation, please let us know by completing this form.