Employer: Philips – Healthcare
In this role, you have the opportunity toUnder limited supervision, the Quality & Regulatory (Q&R) Post Market Surveillance (PMS) Data Analyst / Scientist is responsible for developing and implementing effective data analysis and visualization. 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.This role will specifically support our Diagnostic Imaging (DI) businesses, which include Magnetic Resonance (MR), Computed Tomography and Advanced Molecular Imaging (CTAMI), Diagnostic X-ray, and associated imaging components businesses.You are responsible forActivities related Trending and Escalation:· Developing dashboards and data visualizations needed to effectively monitor Post Market Surveillance data to assure Patient Safety and Product Quality · Able to create programs in Python, R, SAS, Excel, Minitab, etc that integrate data from multiple databases and output the data in visualizations which aid in presentation · Responsible for working with statisticians to assure proper statistical techniques are applied to all trending methods · Working with the various Key Performance Indicators (KPI) owners to maintain oversight of all KPIs and ensuring accuracy of data reported to the leadership team· Responsible for continual review of data that is used 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 trending procedures and trending analysis validation in compliance with regulatory requirements· Develop and deliver training materials to aid teams with their understanding of trending methods· Ability to explain trending procedures during regulatory audits, if necessary. Activities related Complaint Handling:Continuously improves Complaint Handling trend reports and reporting to meet changing needs of business. With minimal supervision, works with Philips associates from all departments, including Medical Affairs, clinicians, engineers, and Regulatory Affairs associates, to develop complaint reports that appropriately address questions posed. Possess the ability to work independently with minimal supervision as well as the ability to guide others in the Complaint Handling group with regard to data analysis.Travel – up to 30% Other:· May receive technical guidance on complex problems, but independently determines and develops approaches and solutions. · Ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, MDSAP, EUMDR, etc.To succeed in this role, you should have the following skills and experienceBachelor’s degree in Engineering, Computer Science, Statistics, Mathematics, Data Analytics or similar technical areaMaster’s degree desired in Engineering, Data Analytics or similar technical area Must possess understanding of engineering and working knowledge of applied statistics. Experience working in regulated environments and/or knowledge of regulatory requirements, such as FDA Quality System Regulations, 21 CFR Part 820, and MDD/MDR, and international standards, such as ISO 13485, ISO 14971, and IEC 62304, is preferredUS work authorization is a precondition of employment. The company will not consider candidates who require future sponsorship for a work-authorized visa. 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 age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.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.