Verily
Quality Systems Manager
Verily, San Bruno, California, United States, 94066
Who We AreVerily is a subsidiary of Alphabet
that is using a data-driven approach to change the way people manage their health and the way healthcare is delivered. Launched from Google X in 2015, our purpose is to bring the promise of precision health to everyone, every day. We are focused on generating and activating data from a variety of sources, including clinical, social, behavioral and the real world, to arrive at the best solutions for a person based on a comprehensive view of the evidence. Our unique expertise and capabilities in technology, data science and healthcare enable the entire healthcare ecosystem to drive better health outcomes.Description
Verily is seeking a highly skilled and experienced Quality Systems Manager to join our dynamic Quality Leadership Team. This pivotal role will be responsible for managing and overseeing critical quality systems and processes, including QS issue management, corrective and preventive actions, IT Systems and Tools utilized within the QA function, and document control, and coordinating quality management review content and readiness.The Quality Systems Manager will lead a diverse team of QA professionals, ensuring the effectiveness of our quality systems while driving continuous improvement initiatives.Responsibilities
Manage and oversee the identification, investigation, and resolution of medical device and QMS process related issues. Oversee the CAPA process to ensure timely and effective corrective and preventive actions are implemented.Oversee the selection, implementation, and maintenance of IT systems and tools used within the QA function. Ensure that these systems are effectively integrated, compliant with regulatory requirements, and support the overall quality and business strategies.Ensure the proper management of quality documentation, including creation, revision, approval, distribution, and archiving. Maintain document control processes that comply with industry standards and regulatory requirements.Coordinate content and readiness for quality management review meetings, ensuring that key quality metrics, trends, and improvement actions are effectively monitored and summarized.Manage and develop a team of QA professionals, fostering a culture of collaboration, innovation, and continuous improvement. Provide guidance, mentorship, and performance feedback to team members.Minimum Qualifications:
Bachelor’s degree in Engineering (e.g., Biomedical, Mechanical, Electrical) or a related field. Advanced degree preferred.Minimum of 8+ years of experience in Quality Assurance within the medical device industry, including experience with traditional medical devices and Software as a Medical Device (SaMD).Proven experience in managing and developing teams. Strong leadership skills with the ability to inspire and drive a high-performance culture.In-depth knowledge of quality systems, nonconformance management, CAPA processes, and document control. Experience with quality-related IT systems and tools. Thorough understanding of FDA regulations, ISO 13485, and other relevant quality standards in the medical device industry.Preferred Qualifications:
Ability to think strategically, with a strong ability to develop and execute strategies that align with business objectives.Excellent communication and interpersonal skills, with the ability to effectively interact with cross-functional teams, senior management, and external stakeholders.Strong analytical and problem-solving skills, with a track record of successfully resolving complex quality issues.The US base salary range for this full-time position is $147,000 - $208,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus or benefits.#LI-EB1Why Join Us
Build What’s Vital.At Verily, you are a part of something bigger. We are a diverse team of builders innovating at the intersection of health and technology—united by a shared spirit of curiosity, resilience and determination to make better health possible for all. This builder mindset means your fingerprints will be on the work that shapes the future of health.Fulfilling our precision health purpose starts with the health of our Veeps, which is why we offer flexibility, resources, and competitive benefits to support you in your whole-person well being.Our culture reflects the behaviors that stem from living our values every day in how we Innovate Healthcare and Technology, Gain Velocity as One Verily, and Respect Individuals. As One Verily, we uphold our collective accountability to sustain this culture and to create a VIBE (Verily’s Culture of Inclusion, Belonging, and Equitability) where all Veeps feel included, a sense of belonging, and have opportunities to grow.If this sounds exciting to you, we would love to hear from you.You can find out more about our company culture on our
LinkedIn Company Page
and
Verily Careers page .
#J-18808-Ljbffr
that is using a data-driven approach to change the way people manage their health and the way healthcare is delivered. Launched from Google X in 2015, our purpose is to bring the promise of precision health to everyone, every day. We are focused on generating and activating data from a variety of sources, including clinical, social, behavioral and the real world, to arrive at the best solutions for a person based on a comprehensive view of the evidence. Our unique expertise and capabilities in technology, data science and healthcare enable the entire healthcare ecosystem to drive better health outcomes.Description
Verily is seeking a highly skilled and experienced Quality Systems Manager to join our dynamic Quality Leadership Team. This pivotal role will be responsible for managing and overseeing critical quality systems and processes, including QS issue management, corrective and preventive actions, IT Systems and Tools utilized within the QA function, and document control, and coordinating quality management review content and readiness.The Quality Systems Manager will lead a diverse team of QA professionals, ensuring the effectiveness of our quality systems while driving continuous improvement initiatives.Responsibilities
Manage and oversee the identification, investigation, and resolution of medical device and QMS process related issues. Oversee the CAPA process to ensure timely and effective corrective and preventive actions are implemented.Oversee the selection, implementation, and maintenance of IT systems and tools used within the QA function. Ensure that these systems are effectively integrated, compliant with regulatory requirements, and support the overall quality and business strategies.Ensure the proper management of quality documentation, including creation, revision, approval, distribution, and archiving. Maintain document control processes that comply with industry standards and regulatory requirements.Coordinate content and readiness for quality management review meetings, ensuring that key quality metrics, trends, and improvement actions are effectively monitored and summarized.Manage and develop a team of QA professionals, fostering a culture of collaboration, innovation, and continuous improvement. Provide guidance, mentorship, and performance feedback to team members.Minimum Qualifications:
Bachelor’s degree in Engineering (e.g., Biomedical, Mechanical, Electrical) or a related field. Advanced degree preferred.Minimum of 8+ years of experience in Quality Assurance within the medical device industry, including experience with traditional medical devices and Software as a Medical Device (SaMD).Proven experience in managing and developing teams. Strong leadership skills with the ability to inspire and drive a high-performance culture.In-depth knowledge of quality systems, nonconformance management, CAPA processes, and document control. Experience with quality-related IT systems and tools. Thorough understanding of FDA regulations, ISO 13485, and other relevant quality standards in the medical device industry.Preferred Qualifications:
Ability to think strategically, with a strong ability to develop and execute strategies that align with business objectives.Excellent communication and interpersonal skills, with the ability to effectively interact with cross-functional teams, senior management, and external stakeholders.Strong analytical and problem-solving skills, with a track record of successfully resolving complex quality issues.The US base salary range for this full-time position is $147,000 - $208,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus or benefits.#LI-EB1Why Join Us
Build What’s Vital.At Verily, you are a part of something bigger. We are a diverse team of builders innovating at the intersection of health and technology—united by a shared spirit of curiosity, resilience and determination to make better health possible for all. This builder mindset means your fingerprints will be on the work that shapes the future of health.Fulfilling our precision health purpose starts with the health of our Veeps, which is why we offer flexibility, resources, and competitive benefits to support you in your whole-person well being.Our culture reflects the behaviors that stem from living our values every day in how we Innovate Healthcare and Technology, Gain Velocity as One Verily, and Respect Individuals. As One Verily, we uphold our collective accountability to sustain this culture and to create a VIBE (Verily’s Culture of Inclusion, Belonging, and Equitability) where all Veeps feel included, a sense of belonging, and have opportunities to grow.If this sounds exciting to you, we would love to hear from you.You can find out more about our company culture on our
LinkedIn Company Page
and
Verily Careers page .
#J-18808-Ljbffr