Director Quality Management, Infusion Disposables
Job Description Summary
Reporting to the Sr. Director Quality, EMEA MDS WWISD, the Quality Director provides leadership to technical and people managers. The role significantly influences the strategy and assures alignment of tactics to achieve objectives. Through outstanding communication; effective problem solving and active management of ambiguous situations; Director ensures product safety, product quality and compliance with all relevant global regulations and customer expectations. Success is measured in terms of the frequency and scale of product quality and organizational issues. Gains in the financial, human resource and or public position of BD, correlated with quality achievements, are equivalent priorities. Through stakeholder engagement; people development and departmental refinement; the Director produces durable and industry leading results for the key business drivers.
In general, the Director, Quality Management is responsible for assuring that the organizational structure, responsibilities, procedures, processes, and resources for the implementation of the Quality Management are adequate to meet the needs of the business and to conform to all applicable regulatory requirements, including all adopted industry standards and BD Corporate Quality Policies. The Plant Quality Leaders listed below have reporting responsibility to the Director, Quality Management and are under their functional authority. This includes authority/responsibility for career growth potential, salary and other compensation changes, termination and recruitment/hiring of a Plant Quality Leader. This relationship and authority also apply to Quality Managers/Engineers assigned to new product development Teams or Platforms. The role of the Director, Quality Management is to assure an effective resource/partner to both operations and core team leaders and can carry out responsibilities and make appropriate quality and compliance decisions.
The Quality Director has reporting responsibility for the following Manufacturing Plants and Unit Quality positions:
Plant Quality Sr. Manager, Tijuana MX (solid line reporting)
Plant Quality Sr. Manager, Hermosillo MX (solid line reporting)
Plant Quality Sr. Manager, Nogales ISD (solid line reporting)
Unit Quality Associate Director, WWISD (solid line reporting)
Manager Sterilization Assurance (solid line reporting)
Manager Customer Compliant (solid line reporting)
Sr. Manager Customer Advocacy (solid line reporting)
The Quality Director is responsible for the manufacturing of WWISD products in Tijuana, Hermosillo and Nogales ISD, and NPD/Sustaining Engineering in San Diego and Brea.
This position serves as the Management Representative for Quality for the Tijuana/San Diego/Brea facilities and has the authority and autonomy to provide independent Quality and Compliance oversight over these locations. The position also has the authority to assure that all BD MDS ISD products are designed and manufactured utilizing systems which comply with current Industry and Government Standards and conform to customer expectations for Safety and Effectiveness.
Living the BD Values
- We do what is right
- We thrive on innovation and demand quality
- We are all accountable
- We learn and improve every day
- We help each other be great
Responsible for the development and continuous improvement of the Quality Management function within the WWISD business. This includes appropriate training and accreditation to ASQ and other relevant professional standards, certification to six sigma competencies and participation in leadership and skill development training. The Director Quality Management will promote and develop Diversity as a key element of high performance. Engage with (or may lead) global quality networks as well as the business unit and associates toward the effective promotion and alignment of organizational goals to the company’s mission and vision. Ensure the plant(s)/functional quality organization is (are) designed and resourced to fulfill its obligations and to comply with applicable regulations and procedures. Mentor and develop personnel, including dedicated succession planning and contingency management. Effectively navigate and lead through the challenges of change and establish global stakeholder engagement focused on win-win solutions. Continuously evaluate progress toward objectives adapting them to meet customer and business needs Pursue and actively manage key stakeholder relationships that support the broader strategy that are impacted by plant/business/function objectives Manage customer impacting issues; prioritizing quality and compliance minded solutions that uphold the company and its standards. Maintain positive and cooperative communication and collaboration with all levels of employees, customer, contractors, and vendors. Perceived as thought leader possessing subject matter expert knowledge of global regulations. May have P&L accountability Significantly contribute to development of local and/or global strategies. Accomplishes tasks through highly experienced professional specialists or manager. May act as “management representative” for notified bodies and liaison with regulatory authorities and customers, by hosting and managing related audits and ensuring effective resolution. Serves on Leadership Teams such as the Platform Leadership Team (PLT) Build an influential and effective network and communication with leadership team members for identifying quality improvement opportunities to evaluate, propose and implement new processes and technologies to optimize efficiencies. Develop the Unit Quality Management strategy in collaboration with the WW VP and Senior Director ISD Quality Management. Execute, measure and report on the progress of the Quality Management Strategic initiatives to BD, MDS, and ISD Senior Management. Continuously apprise Senior Management of the level of quality throughout the Business Unit(s) . Assure Business Unit(s) wide policies, procedures and systems are designed and implemented to produce products which conform to established quality standards and comply with Industry and Government Standards. Responsible for delivering key elements of the MDS and ISD Management Review (QMS, Process, and Product Performance Issues etc.). Support manufacturing sites with appropriate technological and problem-solving skills and resources to prevent and or minimize adverse situations. Provide technical support to the Customer Facing Team to establish the ISO Product Value Stories. Assume a leadership role in continuous improvement of current practice to improve quality and worldwide market share.
Directs and controls the activities through designated managers who have overall responsibility for the successful operation of those assigned areas.
EDUCATION AND EXPERIENCE REQUIREMENTS
Typically requires a minimum of a bachelor’s degree in science, engineering, or other relevant discipline, with a minimum of twelve years of relevant experience.
Primary Work LocationUSA CA - San Diego - Road to the Cure
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