QA Complaint Coordinator
Job TitleQA Complaint Coordinator
As the QA Complaint Coordinator, you will be the vital first step in the Volcano complaint management system to provide exposure to all aspects of the product from an engineering, quality assurance, use and customer satisfaction perspective. Our work environment is dynamic and fast paced. The position is perfect for an individual who pays attention to details and can exercise good judgment.
- Triage complaint for potential safety; notify management or designee of potential safety cases
- Interface with engineering, sales, clinical, other division's complaint staff and other internal departments
- Review complaint histories and identify trends; escalate significant issues to QA management as needed
- Continuously working to improve the complaint handling process
- Work with the Customer Support team (Sales and Clinical Force, Technical Services, Customer Service, and Other Volcano Divisions) to obtain customer complaint clarification and customer follow-up documentation, including product return and detailed complaint information
- Assist with the determination of MDR reportability
- Assist with tracking required MDR report dates to assure reports are not late
- Create and submit MDR reports and other appropriate document to the FDA and other regulatory authorities
- Review appropriate criteria for closure of complaints
Education & Experience you will bring to the role
- Minimum Associates degree or equivalent combination of education and experience
- Minimum of 3 years' experience in Medical Device/FDA regulated industry preferably in complaint handling and/or quality assurance role
- Knowledge of Quality System Regulation 21CFR820/ISO 13485/21CFR803
- Must be proficient in English (READ,SPEAK, WRITE)
- Requires intermediate skills with various computer programs including Microsoft Office products
- Must be able to manage phone system, and answer customer inquiries in professional manner
- Must be able to work well in stressful environment with multiple priorities
- Experience with Sales Force data base, or similar complaint management program a plus
- Proficient with the use of Microsoft Excel strongly desired
- Ability to accommodate changing work hours to accommodate demand/work load
Here at Philips WE ARE Working Together for a Better Tomorrow:
Philips' dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people.
Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.
Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what's next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.
Thanks to our employees, we are at the forefront of the Healthcare industry. Healthcare providers, backed by our many market leading solutions, are able to diagnose confidently, improve care, and increase the quality of life for patients across North America each and every day.
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Advance your career in an environment that supports work-life balance, health & well-being and continuous learning. Making a difference begins right here, where you come first.
Ready to start improving lives by putting your personal skills & passions to work? Apply Today! Find out more info about Philips at www.philips.com/na/careers
Philips is an equal employment employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
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.
In case of difficulties with your job application please send an email to [email protected]
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