Post Market Surveillance Manager
In this role, you have the opportunity to
The Post-Market Surveillance team is responsible for monitoring, investigating, tracking and reporting on the performance of all Hospital & Respiratory Care products in the field. This activity is undertaken primarily through the management of the Complaint Handling System. The team is responsible for global vigilance reporting of individual events, field actions, communications with regulatory authorities and Notified Bodies, and creating the data required to drive business critical decisions at the executive level.
In this role, you will lead a team of individuals for the Hospital & Respiratory Care business unit with primary responsibilities in ensuring compliance in a fast-paced, changing global regulatory environment. The role includes day to day management of complaint handling and medical device reporting processes to ensure continued control, development, and implementation of strategies to ensure sustained regulatory compliance, and driving a culture of continuous quality improvement. The PMS Manager provides tactical guidance and solutions to maintain process effectiveness and efficiency while coaching and mentoring associates. This role interfaces with all elements of the quality management system, Hospital & Respiratory Care business, global Philips businesses and markets, regulators, and notified bodies.
You are responsible for
- Manage a team of associates to maintain and improve complaint handling system for high volume process in accordance with established Key Process indicators
- Ensure appropriate and timely in-flow of customer complaints
- Measure, monitor, and control the complaint handling system; implement actions as necessary to meet goals
- Formulate and recommend solutions in the application of complaint handling strategies
- Manage a team of associates to ensure timely global medical device reporting
- Establish and maintain required electronic reporting capabilities
- Ensure timely reporting via market group partners and authorized representatives
- Evaluate current regulations, standards, and guidance impacting Post Market Surveillance systems on an ongoing basis and implement solutions to ensure continued regulatory compliance.
- Develop and implement Post Market Surveillance process changes to align with interpretation
- Ensure alignment with Philips level strategies for regulatory compliance
- Implement and maintain post market surveillance planning process
- Identify and escalate product issues identified in the field commensurate with risk (both potential severity and probability increases)
- Apply Risk Management File and Clinical Evaluation content to Post Market Surveillance processes
- Ensure appropriate documentation of key data, analysis, and decisions in complaints and supporting documents and records
- Develop and deliver post market solutions to support new business / distribution channels / projects
- Act as a liaison between Post Market Surveillance and other QMS elements (Design Quality Engineering, Risk Management, Clinical Affairs, Regulator Affairs, Marketing, Product Management, Engineering, Service)
- Lead / participate on project teams to implement solutions to Post Market Surveillance issues
- Enable a culture of continuous improvement by identifying individual opportunities for improvements and leading / participating in project level activities; deliver results using LEAN concepts
- Lead the team as a people manager, motivate the team and drive defined performance outcomes; Develop harmonized goals and objectives
- Perform general Quality Assurance and Post Market Surveillance related duties on an as needed basis to support department objectives and business needs. This includes but is not limited to:
- Generating quality data for analysis, management review or in support of other objectives.
- Supporting internal and external audits and field actions as necessary.
- Support CAPA process activities for both product and process related issues.
You are a part of
An organization that believes-what you do every day can contribute to the innovative health technologies and solutions we develop that make a positive impact on billions of people every year. Including you. Because you’ll find when you work at Philips that your professional and personal lives often intersect in unexpected and fulfilling ways. It’s our mission to improve people’s lives through meaningful innovation and we want you to play a central role in this by leading teams, driving projects, thinking strategically and inspiring colleagues from all over the world.
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 of Science in an engineering, medical, or scientific discipline
- Minimum of 2 years management experience
- Minimum 5 years’ experience in the medical device or other regulated industry; familiarity in quality complaint handling, detailed product investigation, and Quality Management Systems
- Applied knowledge and understanding of global medical device regulations
- Experience with statistical analysis concepts and techniques
- Demonstrated success in project management, teaming and influencing others to achieve results
- Advanced degree preferred
- Experience with process improvement, six-sigma, lean manufacturing, or equivalent
- Experience with electromechanical devices supporting respiratory and pulmonary applications
- Experience teaming and interacting on a global scale
In return, we offer you
The opportunity to be part of an organization that is committed to touching 3 billion lives worldwide. The opportunity to use your skills to support products which provide lifesaving diagnostics and therapy. A chance to grow your professional skills in an environment that values diverse ideas and creative approaches.
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 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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