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BD (Becton, Dickinson and Company) Director - Infusion Quality Engineering (NewCo) in Andover, Massachusetts

Job Description Summary

The Director of Quality Engineering is responsible for strategically leading quality activities in support of new product development projects for a business platform within the Diabetes Care Business Unit. The Director of Quality Engineering will serve as a functional representative on the business platform leadership team and will be responsible for design, modification and implementation of the quality system requirements to support platform needs. The individual in this position will be responsible for developing quality objectives in support of the business platform and determining resource needs and capabilities needed to support the execution of those objectives. The scope of the quality engineering function includes product and process design, verification and validation activities, risk analysis, design transfer and contract manufacturing establishment, as well as all other aspects of design control and other applicable regulations.

As the Diabetes Care business intends to spin-off, this role will work with cross-functional leaders at the Andover site to steer innovation in various product development efforts, including potential due diligence responsibilities.

Job Description

Responsibilities

  • Upgrade Diabetes Care Quality System to align with the business platform needs, and applicable regulatory and BDX requirements, consistent with design and development of complex electromechanical products.

  • Recruit, manage and develop capable, competent and flexible quality engineering organization in support of the business platform needs.

  • Work with cross-functional team to identify external partners for contract manufacturing of complex electro-mechanical equipment ensuring compliance to all applicable requirements and standards

  • Continuously manage relationships with external manufacturing organization(s) to ensure consistent delivery performance of high-quality product

  • Ensure that all product development projects within the business platform are executed in compliance with Diabetes Care quality system and applicable World-Wide regulations.

  • Ensure robust execution of the design verification, validation and risk management activities are carried out for all aspects of product development activities within the business platform.

  • Responsible for integration and alignment of quality functional activities across multiple projects within the business platform.

  • Define appropriate quality requirements and manage key contractors and suppliers contracted in support of the business platform.

  • Set-up and manage quality agreements with key suppliers and contractors in support of the business platform.

  • Responsible for performance management and career development of the Quality Engineering group in support of the platform.

Experience & Education

  • Minimum of a Bachelor Degree in science or engineering. Advanced degree / MBA a strong plus.

  • Minimum of 10 years of experience in a quality management role in a regulated medical device industry with focus on design, development and commercialization of new products and technologies. Expert in Design Control implementation and execution.

  • Experience with complex medical devices containing electronics, software and hardware, implantable devices is a strong plus.

  • Minimum working experience of 20 years working in a Medical Device regulated environment in compliance with WW regulations.

Knowledge, Skills and Abilities

  • Demonstrated technical understanding of the various Quality Sciences that fall within the scope of the QE Functional responsibilities.

  • Demonstrated ability to build and manage highly motivated, competent and experienced quality engineering organization and to foster a team-oriented approach.

  • Experience in managing complex relationships with key co-development partners, suppliers, contractors and customers.

  • Prior experience, knowledge and understanding of software validation.

  • Proven ability to communicate, influence and educate other functions in quality engineering methodologies.

  • Strong customer focus, highly organized, responsible, and detail oriented.

  • Effective written and verbal communication skills.

  • Ability to prioritize and process high volume of work while maintaining the highest quality.

  • Must be able to identify and resolve problems and requests in a proactive and timely manner.

  • Must be able to gather, analyze and exchange information skillfully.

  • High level of professionalism.

  • Self-starter with the desire and ability to take initiative on projects.

  • Demonstrated ability to work independently under time constraints and to manage competing priorities and deadlines efficiently.

  • Proven ability to work as a part of a complex multi-functional organization.

  • Must be able to travel up to 15-20% of time as necessary.

Primary Work Location

USA MA - Andover

Additional Locations

Work Shift

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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