| Quality Assurance Specialist, Devices | Sep 15, 2009 | ||
| Lionville, Pennsylvania | |||
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| Company Overview: | |||
| West Pharmaceutical Services, Inc. (West) is a global pharmaceutical technology company that applies proprietary materials science, formulation research and manufacturing innovation to advance the quality, therapeutic value, development speed and rapid market availability of pharmaceuticals, biologics, vaccines and consumer healthcare products. West is the world’s premiere provider of standard-setting systems and device components for parenterally administered medicines and an emerging leader in the development of advanced formulation technologies for the transmucosal delivery of drugs. Internationally headquartered in Lionville, Pennsylvania, West supports its partners and customers from 50 locations throughout North America, South America, Europe, Mexico, Japan, Asia and the Pacific and Australia. For more information visit West at www.westpharma.com. | |||
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| Description: | |||
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FUNCTION: Manage and coordinate all complaints submitted for medical devices and determine the reportable nature of the complaint. Issue reports and complaint data summaries to management and agencies as needed. ACCOUNTABILITES: 1. Manage all complaints submitted for medical devices and determine if the complaint is reportable or non reportable per current regulatory requirements. 2. Support Regulatory Affairs as needed with reportable events. 3. Manage the Post-Marketing Surveillance program. 4. Enter customer complaints, ensure accuracy of inputs, and issue summary reports to the customer. 5. Coordinate West resources to react to complaints and respond effectively. 6. Interact directly with customers and West personnel in support of complaint needs. 7. Issue summary reports in support of trend analysis, defect type(s), to management on a periodic basis. 8. Coordinate customer accommodations resulting from the customer complaints. 9. Work within the QA group and operations to meet target customer satisfaction goals for reduced turnaround time and quality of responses. 10. Other responsibilities as assigned. BASIC QUALIFICATIONS: Education: BS in nursing or equivalent medical field Experience: Minimum 1-2 years clinical experience with 1-2 years medical device assessment/reporting.
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| Benefits: | |||
West has a lot to offer from compensation that is competitive within the industry to a comprehensive package of benefits that includes:
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