Employment Type: Full-Time
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 request. You may contact 888-367-7223, option 5, for assistance.
In this role, you have the opportunity to
Support post market activities and other quality tasks for the Hospital Respiratory Care business unit. These activities focus on the process for global medical device reporting to competent authorities and includes review and evaluation quality complaints for fielded product which may represent reports of adverse events and/or critical device malfunctions and timely processing of the reports required for compliance to global regulations and standards.
You are responsible for
* Handle the receipt, processing, monitoring, and reporting of product defect complaints.
* Make MDR/Vigilance reporting determinations, investigate document the all activities creating the summaries of the investigation.
* Document product complaints into the TrackWise database for trending and analysis, and ensure the complaint process is completed in accordance with local/corporate procedures, follow the complaint file all the way until completion.
* Interfaces with customers/patients to gather additional information required for complaint initiation/investigations, including the retrieval of product samples and or durable equipment retrieval for evaluation, ensures that complaints from multiple sources are tracked.
* Determine product and incident complaint codes based on the master symptom code severity list.
* Apply knowledge of device regulatory requirements in order to support the Post Market Surveillance reporting process and evaluates complaints for reporting.
* Partner with other departments to resolve product problems and provides feedback to customers as needed.
* Assist with review of the timely coding of completed investigations, closure of all complaint files, and ensures that all pertinent information is contained consistently and uniformly within the file prior to closure.
* Review and comply with the all applicable company policies and procedures, local, state, and federal laws and regulations.
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'll find when you work at Philips that your professional and personal lives often intersect in unexpected and fulfilling ways. It's 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
* Bachelor's degree or higher degree in scientific, health care, nursing, emergency medicine, or related field- or relevant years' work experience.
* 5+ years of experience in a medically regulated and technical environment in (FDA Class I or II equivalent - Class III a plus)- Highly Preferred
* Experience working in databases such as TrackWise, SAP, OneEMS/Salesforce, ServiceMax - Highly Preferred
* Proficiency using office tools such as Microsoft Access and Excel, ClearQuest, and various other computer software applications.
* Must be able to work under pressure to meet regulatory reporting time frames and company requirements.
* Strong sense of responsibility and self-motivation with demonstrated ability to function independently and in a group environment.
* Requires the proven ability to consistently meet and/or exceed goals. Must be capable of making commitments, setting priorities, and delivering results on time and on budget. Effective team building skills.
* Able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives.
* 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 opportunity to be part of an organization that is committed to touching 3 billion lives worldwide. The opportunity to use your skills to support products which provide lifesaving diagnostics and therapy. A chance to grow your professional skills in an environment that values diverse ideas and creative approaches.
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. Learn 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 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.
Equal Employment and Opportunity Employer/Disabled/Veteran
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