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Job Information
Job title

Senior Product Analyst

Company Boston Scientific
Wage Not specified
Location United States, California, San Jose
Employment type Full Time
Education Not Specified
Year Experience 3 - 4 Years of Practical Experience
Travel None
Published on 9/23/2004
Description
The Sr. Product Analyst investigates and resolves product complaints of all products and ensures all Medical Device Reporting (MDR) requirements are maintained. Works within the Complaint database, develops/maintains MDR database and complaint trend analyses.

1. Reviews incoming complaints for reportability and follows up with external customers as required.
2. Oversees customer complaint handling by ensuring receipt, analysis, and investigation of returned products, monitoring and reporting of all complaints.
3. Provides technical solutions to address and expedite product complaints under the company's complaint policy and procedures, and ensures compliance with federal regulations.
4. Maintains product defect investigation operating procedures, updating with new product knowledge and techniques.
5. Provides technical expertise to enhance complaint-processing systems.
6. Contributes to projects regarding process improvements.
7. Reviews Complaint files for Closure.
8. Provides MDR reports.
9. Conducts MDR review meetings. Prepares and distributes MDR review meeting minutes.
10. Investigates MDRs, ensures closure, maintains MDR database.
11. Monitors complaint activity and provides suggestions to appropriate company authorities to modify existing manufacturing or packaging processes based upon pattern and related analyses.
12. Presents monthly and quarterly trend reports. Prepare and distribute trending meeting minutes.
13. Provides MDR and complaint trend information to functional and corporate management as required.
14. Other duties as assigned.

Bachelor of Science degree Engineering field or equivalent combination of education and experience required. Minimum 5-7 years of varied experience in QA/QC manufacturing environment, preferable in medical device or health care industry. 2+ years experience with FDA regulations and medical industry. Familiarity with clinical procedures and practices a plus.df-tc

Experience/Skills
See Description Above

Other desired skills:
Senior Product Analyst
This job has expired.