In this role, you have the opportunity to
Directly execute or manage the coordination of subordinate activities in the operations of the Global Group Function QMS including methods, staffing and cost management.
You are responsible for
Ensures the GGF QMS is deployed in a compliant manner consistent with the standard process as defined by the PEPF.
Monitors the use of local add on procedures by stakeholders of the GGF QMS to augment the PEPF where required using this approach only when justified by a clear rationale.
Manages the operational aspects of the GGF QMS establishing the Quality Manual, Governance Structure, Document Management and Records Control as well the expanding its scope consistent with the needs of the organization through Quality Planning.
Represents the GGF QMS Operations during internal or external regulatory reviews.
Provides oversight and strategic input to the ARIS QMS portal development process to ensure a blue print design is established and deployed to support ARIS portal deployments.
Leads the execution of processes in the operation of the GGF QMS affecting immediate operations that may also have a company-wide affect.
Ensures Quality KPIs are measured, reported and monitored to meet established quality objectives.
Establishes and maintains Intra-Company Agreements with the businesses and markets encompassing the scope of the GGF QMS and its relationship to other stakeholders and monitors its execution in compliance to the agreement.
Establishes operational objectives and work plans and delegates assignments to subordinates in alignment with functional and departmental strategic objectives.
Provides input to upper management on the operational objectives supporting the strategy and implements monitoring methods and reporting to demonstrate their status on an ongoing basis.
Solves problems using in a structure manner to get to root causes and develop clear actions plans to effectively eliminate or mitigate the risk. This includes conducting a logical analysis of the situation or data taking into consideration organizational objectives.
Establishes and adheres to budgets, schedules, work plans and performance requirements.
To succeed in this role, you should have the following skills and experience
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
Bachelor’s degree required in science or engineering fields. Master’s preferred.
Familiarity with global medical device regulations, requirements, and standards to support process planning and resource designation a distinct advantage
10+ years of experience in a QMS environment
Supporting Q&R in developing data system to provide early warning systems across QMS processes to ensure clear issue mechanisms are defined, adhered to, and resolved.
Establishing a strong core PQMS team and drives common goals and objectives to result in improved customer experience, operational excellence & dedicated regulatory compliance. Represents business needs with customer as appropriate to provide updates on product related matters.
Attracting, developing, engaging and retraining team members to ensure strong and talent succession in quality & regulatory organizations.
Drive ambition towards Philip’s people strategy, act as a coach and co-own the career development plans of team members.
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 page on 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 to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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.