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Quality Associate I (3431)

Responsibilities:
Process low-risk (non in-depth) complaints: Collect necessary complaint information Determine reportability of a complaint and submit associated MedWatch reports within 30 days per regulations, following review by higher level specialist Evaluate complaint for need to investigate and coordinate sample retrieval Document investigation and sample evaluation results Respond to customer complaints (written or verbal), following review by higher level specialist Timely closure of complaints, as per procedure Assist senior-level specialists in the processing of high-risk (in-depth) complaints Manage workflow; identify and escalate issues Perform trend reporting and escalate results to appropriate business units for consideration of necessary actions Participate in process improvement activities and projects
Qualifications:
Knowledge of FDA Quality System and Medical Device Reporting regulations (21 CFR 803, 820 and 211). Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures. Solid written/verbal communication and organizational skills. Knowledge and application of computer systems for word processing and complaint management. Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
Education/
Experience:
A minimum of an Associates Degree required in nursing, pharmacy, medical technology, engineering or scientific background (MLT, LPN, RN). Bachelor degree and /or clinical certification (MT, RN) preferred. 0-3 years work experience in a cGMP related industry or in a clinical setting.

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