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| Job Requisition #: | AF12018 |
| Date Posted: | 10/12/2009 |
| Category: | QA Administration |
| Location: | Minnetonka - MN - USA |
About Us |
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| St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. We currently have this position open at our Atrial Fibrillation Division. | |
Job Overview |
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| CAPA Coordinator We are seeking a high caliber, experienced CAPA Coordinator. The CAPA Coordinator will provide program management support to the Quality Assurance group and assist with managing CAPA, QA Metrics, and Field Corrections and Removals programs in support of our Minnetonka manufactured catheter based product line. Impact this role will have: • As CAPA Program Administrator: o Review CPAR and CAPA data submissions for adequacy, completeness, and effectiveness o Tracks due dates, follows up on deadlines, and manages the extension request process o Establishes and maintains CAPA files o Develops and issues periodic CAPA trending reports o Acts as secretary during CAPA meetings, and prepares and issues meeting summaries o Prepares meeting slide presentations • As Material Review Board Administrator: o Reviews NCR data submissions o Compiles periodic NCR trending reports o Prepares and issues meeting summaries o Maintains NCMR files • Prepares and issues weekly Quality dashboards to Senior Management for CAPA, NCMR, Complaints, and other Quality metrics • Performs data entry for CAPA, NCR, RMAs, quality inspections, and other quality systems • Provides general support for the QA department to assure compliance with systems. Assists Marketing when requested. Required Qualifications • High school diploma or equivalent • Minimum of three years of relevant experience • Basic office and computer skills, including proficiency with MS office software such as Word, Excel, and PowerPoint • Strong organizational skills and attention to detail • Proven ability to prioritize and handle a large volume of projects simultaneously Preferred Qualifications • Associate or Bachelor’s degree • Proficient with using Windchill |
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