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Your Search Results
As of February 09, 2010
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Job Title
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Job Category
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Location
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Field Clinical Engineer II
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Field Engineer
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Ann Arbor, MI
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Accountant, Senior
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Accounting
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Austin, TX
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Dir, Fellows Programs
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Training
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Austin, TX
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Dir, Product Marketing
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Marketing
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Austin, TX
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Mgr, Facilities
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Facilities
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Austin, TX
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Purchasing Manager
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Purchasing
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Austin, TX
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Mgr, Recruiting
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Human Resources
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Austin, TX
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Mgr, Sr. Human Resources
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Human Resources
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Austin, TX
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Mgr, Sr. Human Resources
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Human Resources
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Austin, TX
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MANAGER I, QUALITY
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Quality
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Bairro Vila da Serr
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Direct Sales Rep, Cardiology
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Sales
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Baltimore, MD
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Patient Therapy Access, Area Man
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Reimbursement
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Central Region
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Direct Sales Rep, Cardiology
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Sales
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Charlotte, NC
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Direct Sales Rep, Cardiology
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Sales
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Cleveland, OH
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Complaint Coordinator
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Quality Assurance
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Dallas, TX
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Copywriter
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Marketing
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Dallas, TX
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Desktop Support Tech
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Information Technology
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Dallas, TX
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Dir., Complaint Mgmt. Systems
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Quality Assurance
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Dallas, TX
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Electrical Engineer II
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Electrical Engineering
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Dallas, TX
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Electrical Engineer II
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Electrical Engineering
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Dallas, TX
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Industrial Engineer
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Engineering
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Dallas, TX
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Manager, Complaints
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Quality Assurance
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Dallas, TX
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Manager, IT Support
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Information Technology
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Dallas, TX
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Manager, Product Analysis
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Quality Assurance
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Dallas, TX
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Manufacturing Engineering Mgr.
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Engineering
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Dallas, TX
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142 positions matched your search. Positions 1 - 25 are shown.
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Detailed Description |
| Job Title: |
MANAGER SR, QUALITY |
| Location: |
St. Paul - MN - USA
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| Job Category: |
Engineering |
| Shift: |
1st |
| Date Posted: |
08/21/2009 |
| Description: |
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. Headquartered in St. Paul, MN, St. Jude Medical employs more than 14,000 people worldwide and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation.
We currently have the following opening in our Cardiovascular Division:
Manager Sr, Quality
Position Summary: This position is responsible for developing, establishing and maintaining quality programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations. Specifically, this position will provide Quality Engineering Leadership for the SJM CVD Heart Valve Repair and Replacement Product Families.
Essential Functions:
•Provide Quality Engineering leadership in direct support of medical device manufacturing, including:
•Management and development of Quality Engineers and Technicians
•Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization
•Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
•Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
•Define and implement superior Process Control & Monitoring systems for KPIV and KPOV throughout the product lines – Critical Parameter Management
•Provide influential peer leadership with international partner site to drive proactive quality improvements
•Identify Quality Initiatives and lead cross-functional teams to complete them
•Provide proactive, diligent, and fact-based communication to Sr. Management team, peers and team.
•Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
•Lead in the completion and maintenance of risk analysis
•Provides expertise in engineering evaluation and experimentation to determine if product and process capability requirements are being met, and continually improved, within the routine manufacturing process.
•Analyzes quality audit findings and recommends modifications in products or standards. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements.
•Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
•Utilizes Six Sigma and other quality tools to implement process improvements to enhance product quality and reduce process variance by identifying improvement opportunities in regulation compliance, device, process, and system quality, and cost reductions.
•Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and proactive improvements.
•Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
•Be a champion of Quality, Six Sigma, Lean and disciplined problem solving throughout the organization
Qualifications:
•4 year degree; industry certification or advanced degree preferred.
•Class III or II medical device experience
•7+ years in quality management desired with roles of increasing responsibility, impact, and scope within a manufacturing support environment
•Six Sigma Black Belt strongly preferred
•ASQ Certified Quality Engineer or Manager strongly preferred
•Demonstrated performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment
•Ability to travel internationally to support international manufacturing sites
•Demonstrated and impactful experience in process improvement (KPIV, KPOV, Fishbone, Is/Is Not, QFD), Six Sigma, product and process qualification and validation, Process Control & Monitoring (SPC)
•Demonstrated and impactful strong project management and people leadership skills required
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| Requisition #: |
9599 |
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