If you are a colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon requestYou may c ontact 888-367-7223, option 5, for assistance.
In this role, you have the opportunity to
Leads team of investigators responsible to evaluate, investigate, and resolve complaintsCompletes initial assessment of reportability and escalates to the manager when necessary to determine actionAnalyzes complaint data, gather additional data as needed, and partner cross functionally to share feedback to the all stakeholders on potential product improvements, product defects, and safety evaluations, and resolve complaints.
You are responsible for
Work with a variety of diverse persons within the company such as engineers, scientists, clinical specialists, field service & application engineers, and manufacturing personnel to facilitate the complaint handling process globally Provides review of complaint to ensure all information needed for reporting/mdrs is present Determine if further investigation is needed and track investigation to conclusion Writes mdrs/mir reports and submit to the necessary authorities Monitors and improves tracking/control systems for medical device reporting Investigates and prepares response to address competent authority inquiries and provide follow-up Confirm complaint condition and determine corrective action (including capa as needed) Assess if the risk assessment is covering the hazard in the complaint
You are a part of
As a result of philips renewed dedication to quality, it has recently restructured its organization to ensure you and your department have clear works with philips business group and market leadership, and can harness the expertise of five centers of excellence (coes)These 5 coes specialize in the following capabilities: regulatory & clinical affairs, supplier quality, quality management system, quality assurance & engineering, and compliance & audit.
To succeed in this role, you should have the following skills and experience
Us work authorization is a precondition of employmentThe company will not consider candidates who require sponsorship for a work-authorized visa. Bachelor's degree 3+ years of related experience in a medical device or regulated industry. 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, and iso 9001Markets: Local post market surveillance regulation (21cfr, mdd93/42/eec, other applicable market regulations), iso14971 risk management Product knowledge is preferred
In return, we offer you
A path towards your most exciting careerPhilips is growing its marketing capability enterprise wideSucceeding in this global role in a sophisticated environment will open many doors for your long-term career, in other areas in philips or otherwiseWe also believe that we are at our best as a company when you are at yours as a personThus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activitiesFurthermore, philips university is available to all employees for learning and development opportunities.
Why should you join philips?
Working at philips is more than a jobIt’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 continuumOur people experience a variety of unexpected moments when their lives and careers come together in meaningful waysLearn more by watching this video.
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 blogOnce 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 workforceIn 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.
Equal employment and opportunity employer/disabled/veteran
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Lead Complaint Investigator
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