Post Market Surveillance Data Analyst
In this role, you have the opportunity to
Develop and implement effective data analysis and visualization for all of Post Market Surveillance within and support of our Ultrasound business. These activities are in direct support of monitoring and detecting quality and safety signals associated with fielded product performance (e.g., adverse events, product malfunctions). Your role ensures on-going regulatory compliance and continuous product improvement.
You are responsible for
- Responsible for developing statistical methods needed to effectively monitor PMS data to assure Patient Safety and Product Quality
- Responsible for managing the Post Market Surveillance trending processes and assuring proper statistical techniques are applied to all trending methods
- Establishes statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (SPC), DOE).
- Automates data analysis methods
- Working with the various KPI owners to maintain oversight of all KPIs and ensuring accuracy of data reported to the leadership team
- Responsible for continual review of data for the Trending and Escalation procedure (e.g., calculation of upper control limits).
- Assures the data integrity of all output via appropriate verification and validation activities.
- Ability to document statistical-based trending procedures and trending analysis validation in compliance with regulatory requirements
- Develop and deliver training materials to aid teams with their understanding of statistical-based trending methods
- Ability to explain statistical rationale and trending procedures during regulatory audits, if necessary.
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 will find when you work at Philips, that your professional and personal lives often intersect in unexpected and fulfilling ways. It is 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
- BS or MS in Statistics/Biostatistics, Data Science, or an equivalent degree with 2+ years’ experience as a statistician in device/pharma industry
- Medical Device experience is desired but not required
- Experience with Statistical software that integrates large datasets from multiple sources
- American Society for Quality (ASQ) certification, Six Sigma knowledge is desirable.
- Well-developed interpersonal relationship skills
- Proven ability to take independent action to initiate process improvement, when needed
- Proven ability to work in a matrix-like manner where cross-functional interaction is an implicit way of Working
- Proven ability to deliver on delegated work efficiently
- Solid time-management skills to meet deliverables commensurate with a fast-paced environment
- Well organized, able to multitask and prioritize competing tasks
- Able to manage expectations with supervisors, peers and customers
In return, we offer you
At Philips, we strive to make the world healthier and more sustainable through innovation, and our goal is to improve the lives of 3 billion people a year by 2030. This position offers the opportunity to influence regulatory compliance worldwide and directly improve the customer and patient experience. 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.
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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