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| Job Details | Posting Date: 27-Jul-10 |
| Job ID # 130856 | |
| Company: Baxter Healthcare | Contact Name: Human Resource |
| Address 1: One Baxter Parkway | Phone: |
| Address 2: | Fax: |
| City/State/Zip: Los Angeles CA 90039 | E-Mail: timothy_flynn.69713.2451@baxterna.aplitrak.com |
| Web Site: http://www.aplitrak.com/?adid=dGltb3RoeV9mbHlubi42 | |
| Job Type: Job | Title: Sr. Principal Quality Engineer |
| Category: Engineering | |
| Job Responsibilities/Duties: | |
| Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
The Senior Principal Quality Engineer is responsible for supporting and sustaining Renal Quality Engineering activities related to medical device design control and post-market product support for hardware/software systems and associated disposables. Responsibilities include: * Demonstrate expertise and mentor others in the areas of Quality Engineering and worldwide Quality System standards and regulations * Provide leadership role in generating design plans, reviewing design inputs, outputs, verification, validation and design transfer strategies * Lead Risk Management activities for sustaining engineering projects * Demonstrate assertiveness and be able to independently represent the Quality function in various roles such as product support and lifecycle management * Assist in decision making for process and product improvement efforts * Perform quality-related functions for design changes * Perform quality-related functions for global Renal manufacturing facilities and associated manufacturing and supplier changes * Perform quality-related functions for post market activities such as complaint investigation, complaint trending, CAPA, product Manufacturing Hold, event-related Health Hazard Assessment and Field Corrective Action (recall) processes * Preside as subject matter expert (SME) and key participant in compliance audits and FDA/Ministry of Health (MOH) inquiries and inspections * Perform quality-related functions for DHF/risk remediation activities * Some Senior Principal Quality Engineers will be selected to perform supervisory duties and lead other Quality Engineers Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers. EOE M/F/D/V. |
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| Qualifications: | |
| * B.S. in Engineering/Science with 8-10 years of relevant experience in Quality Engineering within a regulated environment (Medical hardware and/or disposables)
* ASQ (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification highly preferred * Corporate Quality or Design Center experience * Design Control and Risk Management experience * Excellent verbal, written communication skills * Strong analytical and problem solving skills * Demonstrated ability to lead others within project or investigational environments * Supervisory experience is a plus |
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| Contact Information: | |
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