| Job Description: |
Summary:
This position is responsible for complaint handling
Essential Duties and Responsibilities:
* Process complaints which may include:
* Collect necessary complaint information
* Determine reportability of a complaint and submit associated MedWatch reports within 30 days per regulations
* Evaluate complaint for need to investigate and coordinate sample retrieval
* Document investigation and sample evaluation results
* Respond to customer complaints (written or verbal)
* Timely closure of complaints, as per procedure
* Manage workflow; identify and escalate issues
* May mentor new team members
* Document daily production output
* May mentor new team members
* Participate in process improvement activities and projects Requirements Qualifications:
* Knowledge of FDA Quality System and Medical Device Reporting regulations (21 CFR 803, 820 and 211)
* Ability to prioritize multiple tasks to ensure compliance with regulations and standard operating procedures
* Knowledge and application of computer systems for word processing, excel and complaint management
* Ability to work with cross-functional teams and to interact effectively with peers, management and customers
* Readily accepting of assignments to new/different products
* Demonstrated critical thinking ability
* Ability to work independently and problem solve
* Solid written/verbal communication and organizational skills
* Project management mindset
Education and Experience:
* Minimum of an Associates Degree required in nursing, pharmacy, medical technology, engineering or scientific background (MLT, LPN, RN) or equivalent experience (defined as a minimum of 3 years of medical products industry experience)
* Bachelor degree and/or clinical certification (MT, RN) preferred 0-3 years work experience in a cGMP related industry or in a clinical setting Project Management experience and/or certification preferred
Doing Work that Matters Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.careers.baxter.com/. EOE M/F/D/V.
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