Job Description Summary

Reporting to the Associate Director, Unit Quality WW IPD, the Senior Manager - Quality Engineering provides direct management and technical support to the Quality Engineers supporting the WW IPD Design Center. The position shall provide quality engineering leadership, oversight, and direction in problem-solving and team-building capabilities. The position is also responsible for sustaining a QMS that complies with applicable standards and regulations, consistent with Corporate and Business Unit policies and procedures. The position shall support new product development and product maintenance through the application of Quality engineering skills for medical devices, assuring that all BD products are designed utilizing systems which comply with applicable regulatory standards and conform to customer expectations for safety and effectiveness.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Responsibilities

Responsible for Design Center Quality deliverables associated with Gravity and Dedicated Sets:

• Lead execution of Unit Quality activities required to meet Business Driver Goals (BDGs), Key Driver Goals (KDGs), and quality metric targets for product platforms and/or processes responsible for as established by the Unit Quality Associate Director, WWIPD.

• Resolution of Quality issues (CAPA, SA, AIs, advanced complaints, etc.)

• Product expert that ensures customer requirements are met.

• Liaises with other functions, such as PMQ, Supplier Quality, Plant Quality, etc. to resolve Quality and Compliance matters.

• Lead a team of Unit Quality engineers to support business needs, including compliance risk remediation, new product development, and cost reduction efforts linked to operational effectiveness.

• Assumes a leadership role in continuous improvement and development of strategies to improve Quality.

• Establish and maintain a team structure that provides excellent customer service and enables optimal use of resources.

• Provide required input for IPD Management Review.

• Support Quality Management System maintenance and improvement activities.

• Implement, measure and report on the progress of the Quality Management critical initiatives.

• Assure that the policies, procedures, and systems are designed and implemented to develop products which conform to established quality standards and comply with Industry and Government Standards.

• Provide the required Quality Engineering support and promote use of statistical tools in product design and development activities.

• Support manufacturing sites, including change control process support, with appropriate technological and problem-solving skills and resources to prevent and or minimize adverse situations.

• Lead Risk Management activities for products under design authority in compliance with ISO 14971.

• Develop and continuously improve skills and adequacy of department resources in order to maintain appropriate levels of Quality Assurance.

• Develop and apply innovative approaches within the Quality Assurance function.

• Provide support/ mentoring/ coaching of QEs for application of technical principles, theories, concepts and quality, tools and systems; develop personnel, including dedicated succession planning and contingency management focused on win-win situations.

• Develops technical solutions to complex problems which require the regular use of technical knowledge, experience, ingenuity, and creativity.

• Provide feedback to prepare budget and adhere to approved departmental budget.

Scope of Responsibilities

• Leads a team of Quality Engineers at the design center. Performs functional activities without appreciable direction.

• Assignments are often self-initiated. Determine and pursue course of action necessary to obtain desired results.

• Plans and participates in subject areas strategically relevant to the business an