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Specialist,Post Market Surveillance

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Quality
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181CZ Requisition #
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JOB SUMMARY:
Responsible for receiving, reviewing and processing all product inquiries for complaint evaluation as required by applicable regulations, standards, and company policy. This position requires understanding of regulatory obligations for compliance within the scope of the department (21 CFR 820.198 and 21 CFR 211). Helps provide customer support and serve as a liaison between manufacturing facilities, distribution centers, customer/technical service and customers regarding product complaints. This role also partners with Quality Engineering on product investigations and trends.

ESSENTIAL/PRIMARY DUTIES:
•Responsible for receiving, reviewing and processing all product inquiries for complaint evaluation as required by applicable regulations, standards, and company policy. 
•Helps provide customer support and serve as a liaison between manufacturing facilities, distribution centers, customer/technical service and customers regarding product complaints. This role also partners with Quality Engineering on product investigations and trends.

 

EDUCATION and/or EXPERIENCE:
•Associates Degree preferred One (1) or more years’ quality assurance experience, or an equivalent combination of education and experience may be substituted
•Requires strict attention to details, careful risk assessment, strong customer service, effective communication, and strong data entre.

COMPETENCY/SKILL REQUIREMENTS: 
•This position requires understanding of regulatory obligations for compliance within the scope of the department (21 CFR 820.198 and 21 CFR 211).

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