Head of Postmarket Surveillance, Oral Healthcare
In this role, you have the opportunity to
Lead our Post-Market team with ownership responsibilities including complaint handling, field quality, and returned goods analysis, as well overseeing personnel and strategy for this team.
You are responsible for
- Responsible for managing the complaint handling unit for Oral Healthcare business.
- Establishes strategy to ensure all complaints are identified and investigated as required to meet international regulatory requirements (21CFR820, ISO 13485, EU MDR, CMDCAS, MDSAP, etc)
- Partners with call center organizations and other Philips Health & Wellness businesses on complaint strategy to leverage best practices and standardize processes as appropriate.
- Ensures reportability assessments are completed and resulting adverse event reports are submitted to regulatory bodies on time and per regulatory requirements.
- Analyzes consumer and return data to identify and collaborates with cross-functional teams to propose design changes to maximize impact to reduce call and return rates.
- Summarizes and reports customer complaint, review, and return data to identify trends and shifts the business can act upon.
- Determines strategy and drives requirements to design products and systems to maximize data on use of returned products in order to derive patterns on product returns and failure modes.
- Establishes and oversees implementation of the strategy for sampling and methods of analyzing returned products.
- Responsible for tracking and meeting metrics for field call rate, product complaints, and adverse event reporting.
You are a part of
Philips Oral Healthcare Product Quality Assurance team in Bothell, WA. Our global Oral Healthcare team provides opportunities to develop your career in a variety of ways; work on global team projects, work with business leaders and influencers to drive change, improve health outcomes and deliver meaningful experiences for patients and families. We are a highly entrepreneurial organization, passionate about developing innovations that meet consumer’s personal health & well-being needs in a unique way, relative to their Mind, Body, and Appearance. Our passion in Oral Healthcare will tap into your innovation with new experiences & desire to make a real impact on our customer’s personal health.
To succeed in this role, you should have the following skills and experience
- 7+ years of experience in a similar role, with similar responsibilities
- A Bachelor’s degree in engineering or science or equivalent experience in the medical device industry
- Demonstrable related experience working in Medical Device and/or other regulated industry (e.g., Pharma, IVD) required
- Working knowledge of appropriate global medical device requirements, regulations, and standards such as ISO 13485, ISO 14971, EU MDD/MDR, and FDA QSR
- Experience with external audit agencies. Experience in development of post market surveillance systems procedures.
- Proven results in leadership and managing others
We offer you
Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have affected billions of lives. Your ideas and ability to deliver will help to transform the future of healthcare and allow you to create your own legacy.
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.
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