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Google

Medical Device Project Manager, Devices and Services

Med-Law
Management
Consulting
Technology
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Minimum qualifications:

  • Bachelor’s degree or equivalent practical experience
  • 5 years of experience within Quality in the Medical Device or Health Care Industry and 3 years experience in Program Management
  • Experience with Complaint Handling in the Medical Device Industry
  • Familiarity with ISO13485, ISO9001 and 21 CFR Part 820 and Quality Management Systems (QMS)

Preferred qualifications:

  • Certified in ISO, American Society for Quality (ASQ) or Six Sigma
  • Experience with both Consumer and Regulated Products. Experience with Risk Management and Compliance
  • Experience developing and managing processes as part of a customer support operations team
  • Strong knowledge of Quality concepts (Statistical Analysis, Audits)
  • Understanding of US and International Medical Device Regulations with experience interacting with Regulatory Agencies (FDA, Notified Bodies, Etc)
  • Ability and experience collaborating cross-functionally with internal teams and stakeholders across different functions and geographies

About the job

Google's mission is to organize the world's information and make it universally accessible and useful. Our Devices & Services team combines the best of Google AI, Software, and Hardware to create radically helpful experiences for users. We research, design, and develop new technologies and hardware to make our user's interaction with computing faster, seamless, and more powerful. Whether finding new ways to capture and sense the world around us, advancing form factors, or improving interaction methods, the Devices & Services team is making people's lives better through technology.

Responsibilities

  • Program manage the execution of a post-market customer care process as part of a medical device Quality Management System (QMS) for the Devices and Services Customer Care (DSCC) division. Execute the process and procedure development and tools integrations, in conformance with US FDA Quality System Regulations, EU Medical Device Regulations and medical device industry laws and best practices.
  • Lead the medical device Complaint Handling process for DSCC to ensure accuracy and compliance with company and regulatory requirements.
  • Manage vendor teams responsible for Medical Device Complaint processes and compliance.
  • Support other medical device quality activities such as supplier controls, internal/external audit, document control, training, and record management.
  • Report to top management on the performance of the QMS (e.g., results of quality audits, corrective actions), including the need for improvement.

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