Philips Post Market Surveillance Engineer in Bothell, Washington
In this role, you have the opportunity to
Be a part of the Post Market Surveillance (PMS) function and play a critical role in the life cycle of PH OHC products, analyzing customer feedback for input into Design and Marketing.
This individual will work with a variety of diverse disciplines within the company such as Engineers, Scientists, Clinical Specialists, Field Service, Application Engineers, and Global Markets to facilitate post market surveillance activities.
You are responsible for
Ensures that processes for specifying and executing field quality analysis actions are adequate to ensure the expectations of all key stakeholders are met
Monitor and coordinate the different sub-system feeders to this process such as complaint handling, Return Goods Analysis output, Claims, Sales, and regulatory submissions.
Prepares key documents such as various Post Market Surveillance internal reports
Continuously track new product quality and provide ongoing information to the Business Unit
Provides recommendation for quality improvement including but not limited to: CAPA, Change Request, SCAR, Risk Assessment.
Create and perform Daily Management
Provides relevant feedback and insights from customers/filed to development/engineering teams to ensure learning from previous projects are captured, analyzed and made available for next project teams.
Participate in Root Cause Analysis, and project improvements
Review, revise and release procedures as required
Improve data analysis and output
Support Audits as applicable
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 the consumer. 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
Bachelor’s degree in Biomedical Engineering, or other Engineering discipline
1+ years of experience in Post Market Surveillance or Complaint Handling reporting and trending role in a Medical Device, Pharmaceutical or Biopharmaceutical industry preferred
Basic understanding of FDA 21 CFR 820 and 803 an asset
Exposure to Good Documentation Practices (GDP) an asset
Ability to work effectively in a highly matrixed organization.
Clear and effective oral and written communication skills
Strong attention to detail and follow up skills
Ability to handle multiple priorities with tight deadlines
Ability to identify gaps and provide solutions to close them
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
In return, we offer you
The chance to enjoy endless opportunities to learn, and develop your career in the directions to which you aspire while making an impact in each role along the way. 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 2030 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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