In this role, you have the opportunity to
Conduct complaint investigations and adverse event reporting, and document results on the complaint record. Work with engineers to coordinate and perform failure analysis. Document and analyze complaint data for issues/trends.
You are responsible for
Enter complaints into the complaint database in a timely manner, normally the same day received
Send a complaint acknowledgement of receipt letter to physicians through the appropriate SPNC sales representative as required
Under supervision, determine if the complaint involves a reportable Adverse Event
Communicate with sales representatives, field service engineers, hospital risk management, physicians, lab personnel, etc. in order to obtain the information required in order to complete the complaint form and adverse event reports
Under supervision, prepare adverse event reports and send them to the appropriate regulatory body (FDA, Competent Authorities) within the required timeframe
Coordinate with field service engineers to obtain and/or clarify laser failure investigations
Complete all required documentation on the complaint form
Send an investigation summary report to the sales representative in order to review with the physician as required
Work with the SPNC receiving department personnel to obtain returned devices
Perform decontamination process for returned devices
Schedule and participate in failure investigations with post-market and the engineering groups
Forward the completed investigation form to the designated individual for completion and closing of the complaint
Provide input for product and process improvements based on failure investigations
Follow current policies and procedures to ensure compliance with all US and international regulations relating to complaint reporting
Participate in both internal and external quality audits (FDA, BSI, PMDA or others)
Perform complaint database searches for input to annual reports, submissions, corrective actions or as requested for engineering. sales/marketing, etc.
Provide complaint metrics used to monitor for monitoring
You are a part of
Our Quality Systems team working with, Quality, Engineering, and Clinical departments to complete complaint investigations.
To succeed in this role, you should have the following skills and experience
BS/BA degree or Associates degree preferred, but not required
Understanding of the circulatory system or ability to learn
Knowledge of or ability to acquire knowledge of US and international regulations for medical device manufacturers, including MDR and Vigilance reports
Strong organization and prioritization skills with ability to manage several tasks simultaneously.
Independent problem solver with excellent written communication skills.
High initiative in a fast-paced environment
Ability to establish priorities, work independently, and proceed with objectives without supervision.
Must have excellent written and verbal communication skills.
Ability to interact with colleagues, face to face and remotely.
Skill to use a personal computer and various software packages experience with Microsoft Word, Excel, and PowerPoint a plus.
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 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.