Philips QMS Transformation Project Leader in United States of America - Home Based, Massachusetts
If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request.You may contact 888-367-7223, option 5, for assistance.
In this role, you have the opportunity to
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, MS and QMS Transformation. This position will work within a global network to communicate and address challenges related to strategic transformation and consolidation projects while driving standardization and compliance in the Business Group.
You are responsible for
Lead 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 QMS Transformation strategic initiatives.
Lead projects for the transformation of the QMS toward the single PQMS structure.
Recognition by business leadership as a key resource to the business's timely global deployments of PEPFs and PIL tools.
Core team member of standardization connecting PEPF BPOs/BPEs with local SMEs
Establishes and executes plans related to MS and QMS Transformation.
Responsible for facilitating meetings that involve eliciting process requirements, gathering business requirements, liaising with users of all skill levels.
Act as a liaison between the technical teams and QMS stakeholders to communicate changes for PEPF releases.
Provide ongoing support for deployments and development of solutions to overcome deployment challenges.
Ensure the in-scope QMS is compliant, effective, and maintained during transformation.
Ensures requirements are effective in all processes in scope.
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
Ensures the PEPF deployment is in line with the evolution of the PQMS supporting simplification and standardization.
Accountable to standardize all in scope QMS processes and ensure the FDA-compliant validation of dependent SW systems.
Accountable for key performance indicators.
Support external audits (FDA, Notified Body, and other external audit support).
To succeed in this role, you should have the following skills and experience
Bachelor’s degree in a scientific/technical field or equivalent medical device certifications
3+ years of experience in the medical device industry or similar work experience
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.
Proven analytical capabilities
Excellent communication, organizational, and project management skills
Successful experience working with global cross-functional teams across multiple work locations
Network oriented and able to interact with different business functions and can work within numerous systems
Work cooperatively in a team environment
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips pageon our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
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