Senior Quality Manager - Post Market Surveillance
Job TitleSenior Quality Manager - Post Market Surveillance
Senior Quality Manager - Post Market Surveillance
In this role, you have the opportunity to
Help build a high growth business that will help improve the lives of millions of people while advancing Philips journey as a global leader in Health Technology.
As Post Market Surveillance manager, you will be part of our Quality & Regulatory Affairs team in Bothell, WA. It concerns a highly accountable role in which you are managing the PMS processes and activities within the Emergency Care and Resuscitation Care business. As a strong leader you are capable of inspiring your stakeholders as well as managing internal and external relations. You will make a difference, can drive change and add a positive contribution to our business transformation process in a dynamic role.
The PMS processes and activities are mainly related to (patient) safety risk assessments, Medical Device / Vigilance reporting, coordinating Post Market Surveillance activities supporting the Customer Complaints process, supporting external audits/inspections
You are responsible for
Manages team of contributors on post market surveillance activities. This includes the investigation of product malfunctions, product design and/or labeling problems, as well as customer dissatisfaction issues, and the regular monitoring and reporting of complaint handling status and metrics. Monitors metrics and drives process improvements based on performance trends.
Leading the team as a people manager, motivating the team and ensuring through good leadership that defined performance outcomes are ensured. This also includes sometimes influencing and managing change without authority in a matrix organization, to achieve the best business results.
Drive product quality improvements and support quality-based processes to ensure the highest quality of our products and solutions as well as compliance with all applicable regulations and requirements. This includes teaming up with business partners to share feedback in order to improve product performance
Ensure proper analysis of product quality, safety, and reliability issues and effective communication to management and other functions. Initiate and facilitate corrective or preventative actions as needed. Ensure quality customer and regulatory communications for current products.
Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives.
Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.
Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
Support and participate in internal and external audits, risk management summaries and health hazard evaluations.
You are a part of
You will be part of the Patient Care Monitoring Solutions business and will report directly to the QMS Manager.
To succeed in this role, you should have the following skills and experience
Management and strong leadership skills in a challenging working environment with a proven track record of 3+ years of experience in managing and transforming a large team.
- Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169;
- Engineering degree or equivalent in relevant experience
- 6+ years of related experience in a medical device or regulated industry preferably in combination with Post Market Surveillance and related processes.
- Has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
- Strong interpersonal and communication skills at all levels in the organization, a real people manager.
- Good analytical skills and process improvement capabilities with the ability to resolve complex issues in creative and effective ways
- Strong written and oral communications skills
- High reliability and quality focus
- High engagement, motivation and flexibility
- Good understanding of customer needs
In return, we offer you
A path towards your most rewarding career. Succeeding in this role in a complex 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.
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.
Find out more info about Philips at www.philips.com/na/careers
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
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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