Senior Director Quality Management, QE & QC

BD (Becton, Dickinson and Company) Veterans Jobs

Senior Director Quality Management, QE & QC in Franklin Lakes , New Jersey

Job Description SummaryThe scope of the Senior Director Quality Management, QE & QC includes the definition and implementation of global Quality Engineering (QE) and Quality Control (QC) strategies and programs. This position works with the central functions, Segment/Business Units and Region stakeholders to develop clear mission and vision for QE & QC and set priorities for the company.

This position is responsible for developing and maintaining a standardized approach to Quality Engineering which includes but not limited to the areas of process development, process validation, and measurement systems. This role is also responsible for developing and maintaining a standardized approach to Quality Controls, working closely with the Operations team, which includes but not limited to production process controls, sampling management, inspection plans, statistical process controls. The Senior Director Quality Management, QE & QC provides assessment of the organization to ensure company quality engineering and quality control programs are aligned with current regulatory requirements, standards, and industry trends.

The incumbent requires significant business quality experience as well as strong quality engineering and quality control knowledge and experience working in an FDA regulated environment. Demonstrate experience with the US FDA GXP, other global regulations, and quality standards and have a working knowledge on quality matters involving the design, development, manufacture, and distribution of medical devices.

Through outstanding communication, effective problem solving and active management of ambiguous situations, the position ensures quality and compliance with all relevant regulations and customer expectations. Through internal and external engagement, and organizational design and development, the incumbent defines the quality engineering and quality control roadmap across company to support key business drivers. S/he will provide motivational leadership, by instilling a bias for action, commitment to excellence, and a high-performing culture.

The Senior Director will report directly to the Vice President Quality Management, Central Quality and is an active member of the Central Quality Leadership team.

Job Description

In accordance with all applicable federal, state, and local laws/regulations and Corporate BD, policies, procedures and guidelines, this position is responsible for:

Develops BD’s Quality Engineering and Quality Control visions and strategies

Ensures that the Quality function is fit to the future – anticipates and plans for capabilities & resources that are needed in the future as the Healthcare environment changes and as the BD strategy evolves

In partnership with IT and the VP’s of Quality for the BU’s and Regions, is accountable for identifying, qualifying, and driving adoption of quality engineering and quality control processes and solutions that drive measurable business outcomes for our business and our customers.

Continually improves the efficiency and effectiveness of the quality engineering and quality control processes.

Works with other Quality Leaders, Research & Development and Operations partners to ensures alignment of R&D and Operations strategies and roadmaps in relation to quality engineering and quality control

Participates in industry trade groups and provide BD point of view to actively influence the development of industry positions that may impact the future of supplier quality management.

Participates in the development of functional strategic plans to support organizational goals and provide guidance to functional areas concerning quality engineering and quality control.

Works with Product Development, Manufacturing, Quality & Purchasing teams to develop and execute quality engineering activities to meet company and function objectives

Provides leadership in design and implementation of world-class quality systems to support the entire product life cycle with focus on business results including reduced cycle time, and lower COGS (Cost of Goods Sold), prevention, detection of defects at earliest phase of product design, continuous improvement and customer satisfaction. Reviews technical problems and global polices & procedures and recommends solutions to problems or changes in procedures

Champions processes covering Quality Engineering and Quality Management to train, support, and encourage team members in the use of quality tools such as root cause analysis, risk analysis, FMEA, Six Sigma and statistical methods

Works with Quality and cross functional partners to develop, improve, and manage product assurance systems such as receiving quality assurance, in-process quality assurance, statistical process control, calibration / preventative maintenance, non-conforming materials, product lot release testing, and finished goods control

Is accountable for Statistical Process Control (SPC) strategy and systems across BD

Drive SPC strategy implementation and works with Quality and cross functional partners to drive systems roll out

Establishes a collaborative community of subject matter experts on SPC and other Quality Control processes and tools to govern and to ensure continuous improvement of these processes and tools

Ensures BD uses best in class tools and techniques to assure products are made and delivered to the right targets and which meet customer needs

The management of the relevant organizational structure and functions worldwide, and the professional development of staff. Develops leadership capabilities within their direct reports and future leaders

Establishes and maintain the operational success of quality engineering and quality control functions, with emphasis on prevention, continuous improvement, and customer satisfaction.

Delivers tangible value to business and functional units through execution of effective quality programs and key initiatives

Reviews and continuously improves the adequacy and application of quality engineering and quality control processes

Sets challenging goals and serves as a thought leader for organizational capability and continuous improvement.

Works with other “central” functional leaders to provide cross-functional direction and support to businesses and regions

This role is required to influence a large, globally based organization to identify and implement opportunities for process/technology/resource optimization and associate capability development.

Primary Work LocationUSA NJ - Franklin Lakes

Additional Locations

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