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Sr Manager, Quality Engineering
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 Quality Manager II will be responsible for globally managing the overall product quality for Baxter Renal Division?s currently marketed Peritoneal Dialysis (PD) systems and disposables. Work with cross-functional departments on Life Cycle Management (LCM) teams, CAPA investigations, complaint investigations and providing quality engineering support to design and process modifications at Baxter manufacturing plants around the world. Supervise and lead a team of Quality Engineers to perform these duties and continuously improve their professional development and job performance.
- Mentor others in the areas of Quality Engineering and Quality System regulations.
- Implement and enforce Baxter quality policies and procedures related to area of responsibility
- Provide leadership for product and process change control including generating Design Plans, reviewing design inputs, outputs, verification, validation and design transfer strategies.
- Lead Risk Management activities for sustaining engineering projects.
- Demonstrate quality 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 improvement efforts
- Support and/or lead post market activities such as complaint investigation, complaint trending, CAPA, and Field Corrective Action processes
- Support global Renal manufacturing facilities and associated manufacturing and supplier changes
- Provide Quality input to DHF/risk remediation activities
- Support internal and external quality audits and FDA inspections
- Implement continuous improvement in products and processes in area of responsibility
- Recruit, retain, train, develop, manage and lead QEs assigned to PD systems and disposables
- Provide inputs to department budgets and assist in controlling expenses
- Provide information used to maintain regulatory filings including technical files
- Collect, monitor and act on key quality metrics
- Minimum of 7 years experience in Quality, Engineering or Manufacturing of complex Medical Devices
- Bachelor?s degree in Engineering or Science required, advanced Engineering degree desired
- ASQ certification (CQE, CMQ/OE, CQA, etc.) and/or Six Sigma certification desired. Certification is expected within 2 years of employment
- Demonstrated success in supervising and managing a team of quality engineers; able to coach, train and develop quality engineers within the company
- Ability to mentor and develop quality engineers to the highest professional and performance standards through appropriate training and certifications
- Knowledge of the global Regulatory and Quality requirements for the manufacture and marketing of medical devices ; knowledge of ISO 13485, FDA Part 820 QSR, ISO 14971, MDD 93/42/EEC and other related regulations and standards
- Direct experience in electromechanical, software-driven, systems is desired
- Strong technical, analytical and problem solving skills, including strong project management skills
- Strong interpersonal and leadership skills, including influencing skills and ability to work in a highly matrixed, consensus-driven cross-functional organization
- Excellent verbal and written communication skills as well as presentation skills
- Experience working with multifunctional, global teams within Baxter desired
- Ability to make quick, sound decisions with limited data
- Ability to solicit feedback and information from others in an open environment
- Ability to build relationships across functional boundaries at multiple levels
- Ability to implement tactical plans with little or no supervision
- Eliminates or minimizes barriers to progress. Anticipate potential conflict situations for proactive solutions Manage conflict situations to result in win-win outcomes
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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