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WHAT
IN
Director of Manufacturing Dev
Job
Baxter International Inc.
US
-
Westlake Village,
California
Job Code - 39871BR
Position - FULL TIME
Job First Active on: Thursday, November 05, 2009
APPLY TO THIS JOB (You will be applying directly to Baxter International Inc. for this position!)
JOB DESCRIPTION: Director of Manufacturing, Dev
Purpose of the job is to assure the provision of compliant high quality devices that meet customer requirements for BioScience Operations. This includes:
* Meeting internal and external customer needs and regulatory requirements for devices
* Assuring that processes and products are safe, effective and compliant
* Developing process understanding and control to produce high-quality products with minimal waste
* Developing a strong, capable, cross-functional, matrix team focused on devices
* Driving continuous improvement
* Allocating resources effectively and efficiently to meet business goals
* Developing and implementing strategic plans
* Building and executing financial plans and projects
Competencies and Areas of Responsibility:
* Responsibility for quality, cost, and performance of all devices used in BioScience, including primary packaging materials used, and purchased diluent vials
* Responsibility for developing a matrix organization to manage all aspects of devices
* Developing efficient, effective procedures and processes for managing device design, development, and procurement, starting with design and ending with customer use / feedback
* Working with Supplier Quality to assure continuous improvement in device supply
* Developing strategies for the procurement of devices, analyzing and selecting optimal suppliers
* Driving continuous improvement in device performance, including ease of customer use and reduction of customer complaints
* Ability to assess and communicate risks in the area of responsibility
* Clear understanding of FDA device regulations and ISO Standards
* Responsibility for the budget and investments
Job Objectives
* Manage the planning and implementation of a cross-functional, matrix organization to manage all aspects of device development and/or acquisition for BioScience.
* Provide expertise to evaluate acquisitions of devices or device manufacturers for BioScience and to provide support for the integration of devices or device manufacturing organization into BioScience.
* Coordinate various functions involved in different aspects of device supply: design, development manufacturing sourcing, documentation / design history files, validation, quality, procurement, supplier performance, exceptions, supply reliability, customer complaints, quality trend review, change management / notification, sterilization, process improvement, regulatory requirements and filings, and risk reduction.
* Develop a framework of procedures and processes to control and optimize all aspects of devices, from design through customer use and feedback that is in compliance with global regulatory requirements, Corporate Quality Systems, and BioScience requirements.
* Hire, train, and develop the team members and the organizational structure.
* Drive continuous improvement in devices through QLP, including working with suppliers (and their suppliers), Supplier Quality, and Purchasing to improve device manufacturing process capability and control plans.
* Develop strategic plan and definition of goals and targets for devices in alignment with BioScience goals
* Report regularly to BioScience Global Operations as appropriate.
* Establish metrics and monitor trends and performance of devices.
* Assure implementation of Baxter's Business Practices.
* Assure close close cooperation across numerous functions and organizations.
* Manage process improvements and changes in alignment with the operations network.
* Develop procedures and processes to assure a logical, efficient approach to devices.
REQUIREMENTS - QUALIFICATIONS: Director of Manufacturing, Dev
Graduated from a science, engineering, or chemical/biological college or university curriculum.
The incumbent must have at least 6 years experience in device manufacturing operations.
Professional experience:
Good professional experience in the device manufacturing industry with a good understanding of current quality and regulatory requirements for medical devices
Excellent change management and people management skills
Strong leadership and communication skills in a matrix organization
Experience in GMP/ISO manufacturing, and device design / development
Special skills:
Organizational talent and good analytical skills
GMP and device regulatory knowledge
Acting with respect and integrity
Proactive communication style
Ability to manage project and start-up situations
Personal discipline
Good command of English
Baxter International Inc.
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