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Summary

Develops and deploys the quality management system for the Brooklyn Park site. Assures systems and procedures for regulatory compliance are established and deployed. Periodically reviews the suitability and effectiveness of the quality system with executive management. Manages regulatory inspections.

Essential Duties and Responsibilities

• Manages the entire Quality organization in a Electromechanical class II device manufacturing facility and directs the department in support of division and/or company-wide initiatives. Quality functions include Laboratories, Compliance, Quality Operations, and Quality Engineering.
• Responsible for results in terms of product quality and conformance to regulations and Baxter policies. Acts as the Management Representative for Quality.
• Develops and deploys the quality system (e.g. management review, CAPA, design control, process control) that ensures products conform to defined requirements
• Understands and deploys processes to assure conformance to regulations and applicable standards in a manufacturing plant. Manages regulatory inspections.
• Periodically reviews the suitability and effectiveness of the quality system with executive management
• Interacts frequently with all levels of internal management as well as across functions and business units
• Manages interactions with customers and regulators concerning the quality of products, systems and processes
• Identifies and manages continuous improvement projects that may span multiple functions or departments with the objective of achieving quality, reliability and cost improvements
• Develops and adheres to the budget
• Leads and develops people in supporting the change process to evolve the plants capabilities according to business needs
• Manages overall coaching, training, development, and succession plans for the team
• Partners with the Plant Manager and Facility Senior Leadership team to further develop the facility (improvement of processes, overall quality, risk profile, customer relationships, etc.)
• A systems level leader, who operates at a systems level and considers how to most effectively balance quality, cost, people and service delivery to optimize Quality·

Qualifications:

• In-depth knowledge of the regulatory environment for the manufacture of electromechanical medical devices and associated devices and labeling
• Strong leadership skills and demonstrated success in multi-location teams
• Demonstrated leadership around cultural and organizational change management
• Strong, proven analytical and problem solving skills
• Excellent and effective verbal and written communication skills
• Verifiable success working with multifunctional, global teams
• Excellent interpersonal communication, influencing, and negotiation skills required

Education and/or Experience

• BS degree in Science or Engineering (Engineering preferred)
  Masters degree preferred
• Minimum of 10 years related work experience in Quality, Manufacturing, or related field in a Medical Device setting—Electromechanical setting preferred
• 7 years of management level experience

Physical Demands

Sitting/standing 8 hours per day. Light lifting may be required on occasion. Ability to gown to go into the clean rooms.

Working Environment

Primarily office environment with frequent access to production areas, laboratories, and production floor.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                               
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Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.