You are responsible for
Day-to-day complaint management of quality, technical and adverse event complaint records, including intake, follow up, triage and entry, in accordance with local and international regulations, guidelines, and applicable directives.
Receipt of initial complaint from any source (external and internal) and ensuring all information/data is accurately captured at point of contact. You may triage calls from various sources for complaints, request for refund, request for replacement product and request for credit.
Maintaining an understanding of information/data required to be collected for technical and adverse events/ reportable complaints to ensure compliance with regulations and directives.
Reviewing complaint data, assessing against reporting requirements and escalating for additional potential safety evaluation. May compose and/or submit Medical Device Reports.
Performing intake / follow up / data entry activities and attaching corresponding source documents in a timely manner in a high volume, fast paced setting per requirements and directives.
Reviewing record documentation and follow-up activities for completeness and timeliness.
Closing files according to established guidelines to meet required timelines.
Maintaining a working knowledge of company policies and procedures, departmental processes, and associated procedures and work instructions, Philips IGT devices for IFUs, Manuals, Promotional Material; coronary and therapeutic procedures.
Informing management of potential safety issues, emerging trends and/or concerns.
You are a part of
This is a Complaints Investigator position for IGT Devices; part of the Philip Image Guided Therapy business group.
To succeed in this role, you should have the following skills and experience
Prior complaint handling experience in a medical device industry.
Knowledge of FDA/QSR requirement & quality systems in Pharma and/or Medical device experience required (i.e. 21 CFR Part 820, Quality System Regulations , 21 CFR Part 803, Medical Device Reporting, The Privacy Rule, HIPAA, ISO 13485)
Demonstrated experience meeting performance requirements.
Solid experience with use of word processing, spreadsheet, database and presentation applications.
Good organizational skills a must. Effective communication skills needed to provide clear and concise information to team members.
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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without 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.