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
Formulates and implements quality, regulatory and compliance policy, and leads and directs organizational development and process improvement to ensure business strategic policy and growth targets are met. Q&R advisor for Global Business Services leadership supporting compliance and standardization in alignment with business strategy.You are responsible for
You are a part of
- Member of Global Group Function QMS Top Management representing Global Business Services in Management Review, CAPA Review Board, Change Control Board and QMS related audits both internal, external and as an extension of internal customer audit requests
- Q&R alignment with process content owners as part of the QMS governance structure
- Drives adoption of standardization to reduce localizations, and where localization is vital, ensures alignment with the process Business Process Owners to ensure it is below the global standardization level
- Supports quarterly adoption of Global Philips Excellence Process Framework releases to Global Group Function QMS approving changes plans as change review representatives and approving document changes for localizations as the compliance approver.
- Ensures the QMS is deployed in a compliant manner consistent with the established Quality Objectives as determined by Top Management and the Management Representative
- Provides direction on the operational objectives supporting the quality strategy and implements monitoring methods and reporting to demonstrate their status on an ongoing basis
- Ensures Quality KPIs are measured, reported and monitored to meet established quality objectives and identifies actions to address gaps in KPI performance
- Prepares required information on the status of performance for quality objectives and service performance standards
- Ensures services executed are accurately identified, communicated and detailed in the Intra-Company Quality Agreement and leads the compliance in the execution of these services
- Establishes operational objectives and delegate assignments to subordinates in alignment with strategic and functional plans
- Solves problems using in a structure manner to get to root causes and develop clear actions plans to optimally eliminate or mitigate the risk. This includes conducting a logical analysis of the situation or data taking into consideration organizational objectives.
- Ensure training plans for all teams and supervises training efficiency for specific QMS processes
- Ensures Quality Plans are in place and optimally executed according to the requirements set forth in the plan.
- Supervises the use of developed automation tools to ensure the tools are inventoried, assessed for quality system impact and validated as required.
- Establishes and adheres to budgets, schedules, work plans and performance requirements
As a result of Philips renewed dedication to Quality, it has recently restructured its organization to ensure you and your department have clear works with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit.To succeed in this role, you should have the following skills and experience
In return, we offer you
- BS required and master's degree or higher educational achievement in relevant field of study desired
- Typically requires a minimum of 7 years of related Q&R experience with 4 years proven technical and managerial leadership
- QMS leadership in architectural design and deployment
- Strong understanding and experience with medical device regulations (e.g. ISO 13485, 21 CFR Parts 11/801/820, EUMDR)
- Strong Business Partnering skills
- Proven leadership in managing a certified QMS including collaborating with notified bodies and other regulatory agencies
- Business Leadership experience particularly in sophisticated multi-disciplinary settings with a global footprint
- Experience balancing compliance, quality and LEAN strategies
- Able to identify best practices and build and influence partner agreement to use these in the promotion of continuous improvement
- Problem solving skills with particular emphasis on LEAN techniques
- Able to take independent action to initiate process improvement, work closely with upper management, work in a matrix organization and work independently with minimal mentorship
- Consistent track record of talent development and building organizational capabilities
A path towards your most exciting career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a sophisticated environment will open many doors for your long-term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.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. Learn more by watching this video .
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 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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