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Director Quality, New Product Development

Apply Now Job ID R-351393 Date posted 10/22/2019


San Jose, California

Job Description Summary

The Director of Quality is responsible for quality leadership and support of new product development and technology research projects for Biosciences Instruments and Reagents. This individual will ensure that the design control requirements are implemented and followed, will support multiple product development projects and will ensure that the quality objectives are met during the product development life cycle. This position will be responsible for supporting development, acquisition and transfer of new products. This position will manage professionals assigned to support core teams in completing projects and tasks, from product inception through launch and maintenance. This role will be an active mentor and coach to ensure products meet quality standards consistent with both Corporate and Business policies, while meeting all design control and other regulatory requirements.

An individual in this position will have the responsibility and oversight for the development and execution of the Supplier Quality Strategy for Instruments and Reagents with goals linked to the Biosciences Business Unit and WW Quality Strategy.

The Director of Quality reports directly to Biosciences Vice President of Quality

Job Description

Key Responsibilities for this Role: 

  • Develop and execute new product development quality strategy for Clinical, Research & scM platforms and establish goals for the quality organization.
  • Ensures quality resources are applied to projects and technical support activities.
  • Ensure effective execution of the quality engineering activities in support of new product development and sustaining engineering projects.
  • Lead, develop, engage and mentor the quality organization in support of Biosciences.
  • Applies and mentors/coaches the application of technical principles, theories, concepts and quality tools to complex systems and process.
  • Manages quality engineering support of Design Control activities, including quality planning, design verification & validation activities, design reviews, design transfer etc.
  • Develop and execute the supplier quality strategy in support of NPD and sustaining activities. Oversee quality activities associated with supplier changes within the manufacturing plants. Continuously improve quality processes and quality system with the goal of improving regulatory compliance, product quality, cost and customer satisfaction.
  • Establish, improve and maintain quality relationships with research, pharmaceutical and medical device partners.
  • Performs, mentors and coaches others on effective root cause investigations and corrective actions to maintain effective and compliant quality systems.
  • Lead implementation and utilization of quality tools such as six sigma, risk management, SPC, root cause analysis, and DOE.
  • Participate and, as needed, coordinate activities of the Quality Leadership Team. 


Policy and Strategy

  • Establishes strategy and direction associated with design control, change control, risk management, validations, supplier qualifications, SAs, CAPAs, statistics & sampling plans, and regulations.
  • Ensures effective implementation for the assigned quality function in alignment with strategic plans established with top management and executive leadership. Contributes to business strategies and plans.

    Sphere of Influence

  • Interacts both internally and externally with executive-level management, requiring negotiation of extremely critical matters. Influences policy making (e.g. via the EQLT). Regularly interacts with various stakeholders on important matters concerning cross-functional, cross-business areas and/or external customers. Understands and works to improve effectiveness of the BD matrix.  Works with manufacturing plants across the network.


  • Broad function-wide objectives are established under the general direction of senior management. Consideration includes: time in the role, expanded responsibilities, size of the business, multi-site interactions, and involvement in global initiatives.


  • Directs and controls the activities of one or more functional areas through designated managers who have overall responsibility for the successful operation of those assigned areas.

    Talent Management

  • Advances the global leadership bench strength of the company.

    Impact of Decisions

  • Decisions and recommendations have a significant long-term impact on the unit and affect the financial, associate, or public relations position of BD.

Primary Work Location

USA CA - San Jose

Additional Locations

Work Shift

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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