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Job TitleQMS Manager-Document Control & Training
Job Description
The QMS Manager-Document Control & Training will play a critical role in ensuring Philips industry leading Hospital Patient Monitoring Systems/Solutions are safe, reliable, and compliant with all applicable internal/external Quality standards/regulations.


Your role:

The QMS Manager is responsible for functional leadership of a team comprised of Document Control Specialists and Training Administrators, as well as overseeing critical QMS activities with a focus on Doc Control, Training and Quality Planning initiatives.
Manages applicable (local) Q&R processes and ensures (local) process ownership for all activities under the PQMS governance in scope. Responsible for tracking and reporting all applicable KPIs on a regular basis to senior management.
Ensures Document Control/Training Administration is established within scope, training profiles are assigned/enforced, all Q&R requirements are effective in all processes in scope and ensures compliant and effective QMSs are maintained in scope.
Effective Business Process Ownership/Expert role for Document Control processes and tools in scope.
Establishes Document & Record support to authors and process owners in defining and producing lean Quality System documents and records; ensure proper quality of the content of documentation and records. Establishes and manages proper document review processes. Establishes, monitors, and responds to metrics on the efficacy and efficiency of the document management system and its ability to support the business.
Leads and supports authors of controlled documents to be lean, well accessible, easy to maintain and according to the agreed look and feel.
The QMS Manager will collaborate with cross-functional teams across multiple work locations.
This
Fremont, CA
based role may require travel up to 10%.


You're the right fit if:

Youve acquired a minimum of 7 years' experience in Quality Management Systems (QMS), training administration and/or document control within FDA regulated medical device environments, with experience in Functional team leadership.
You have strong knowledge/experience with Document Management System tools.
You have a proven track record in leading effective/successful process improvement projects working with cross-functional teams across multiple work locations.
You have detailed knowledge of applicable Quality System Regulations (QSR) and regulatory requirements.
You have excellent communication, organizational, and project management skills, with a strong focus on customer service.
You have a minimum of a Bachelors Degree in a scientific or technical field OR equivalent experience in FDA regulated QMS, Document Control and/or Training Administration.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this
position

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US work authorization is a precondition of employment. The company
will not
consider candidates who require sponsorship for a work-authorized visa, now or in the future.


About Philips:

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.
Read more about our employee benefits.

If youre interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.


Philips Transparency Details:

The pay range for this position is $116,000 to $200,000, annually. The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.