QMS Manager

Job Title

QMS Manager

Job Description

Lead global project execution and provide recommendations to management and business category leaders for Hospital Patient Monitoring (HPM) for projects including, but not limited to, QMS simplification and QMS transformation.

Your role:

• Leading the implementation of the Business' long-range strategic transformation initiatives across the BG.

• Coordination with business stakeholders; communication, promotion, and management of strategic changes.

• Proactive planning and implementation of Quality strategic initiatives

• Establishing and executing plans related to QMS Simplification

• Essential contact/resource for functions E2E, ensuring positive and collaborative relationships with our business partners

• Lead projects to sustain a compliant, effective, and lean QMS structure

• Accountable for transformation-related strategic initiatives supporting the PQMS structure

• Support external audits (FDA, Notified Body, and other external audit support)

• Ensures proper audit planning and schedule meets the requirements of internal policies and external regulations.

• Ensuring compliant and effective QMS are maintained in scope; that the addition and management of any local QMS documents in line with the evolution of the PQMS and that requirements are effective in all processes in scope

You're the right fit if:

• You've acquired 3+ years of experience in the medical device industry or similar work experience.

• Your skills include strong working knowledge of GMP's and other FDA regulations, experience validating application activities, solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues, experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.

• You have a bachelor's degree in a scientific or technical field

• You have been successful in working with cross-functional teams across multiple work locations, have excellent communication, organizational and project management skills, the ability to work cooperatively in a team environment and are network oriented and able to interact with different business functions and can work within numerous systems

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

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 you're 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.

Additional Information

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.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Murrysville, PA; Andover, MA; Cambridge, MA or Orlando, FL.

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

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