Associate Director, Quality Management

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The Associate Director, Quality Management will manage and coordinate compliance of the Global Engineering and Product Development quality engineering functions. This position is responsible for providing strategic direction and support regarding Global Engineering and Product Development with respect to current or emerging quality, regulatory and compliance issues. Responsibilities include assisting in the development of tools or guidance documents to promote consistent implementation of product development processes and quality/compliance strategies.

• Provide mentoring, leadership and guidance to the quality engineering staff and technicians whose function is to develop and optimize design control process, develop and validate new equipment and test methods, assess current or emerging quality and regulatory compliance gaps, control and resolve nonconforming issues and lead continuous efforts.
• Perform aspects of management in the administration of the QA department which include goal setting, planning, organizing, direction, and evaluating direct reports.
• Lead Quality Engineering support for design and changes including incorporation of new products into the product portfolio; responsible for Quality oversight for verification and validation activities.
• Support submissions and renewals on International, CE, TGI, Japan, China, clinical studies, for PIVC products.
• Provide leadership and expertise on a diverse scope of quality/compliance issues where analysis of data is required to draw conclusions, identify risks, and propose possible solutions.
• Oversee International complaints and drive investigations and mitigation efforts along with developing complaint reduction goals for Int’l geographies.
• Understand variances in clinical processes in Int’l geographies and obtain appropriate design inputs.
• Apply appropriate Quality and Compliance principles, tools and techniques to develop and optimize systems that are aligned with the overall company strategy, Global Product Development, Quality Policy and Regulatory requirements affecting international market growth and continuous compliance improvements.
• Establish key performance indicators for the Quality Engineering and ensure support of global business objectives.
• Participate in training and provide input to training of other employees on division and corporate procedures and policies, technical and managerial skills.
• Work with International teams to help with the development of annual international product lines and interpret regulatory requirements in the light of current guidance and international regulatory body field activity.
• Work with cross functional U.S. and International teams to develop, adapt, and execute strategic quality plans for new product development, global product registration, manufacturing, supplier management and product/business acquisitions throughout multiple markets taking into specific cultural and regional considerations.
• Interact with local regulatory agency and oversee test labs to ensure a smooth working relationship, and compliance to BD, FDA and international regulatory requirements during New Product Development, design transfer and global product registration.
• Keep abreast of new methods and developments in the Regulatory and Quality fields and shares attained knowledge with cross-functional team members.
• Ensure international vendor audits are performed per schedule and any deficiencies are resolved in a timely manner.
• Develop plans and strategies to assure BD is successful in all compliance audits.
• Provide effective leadership, communication and training that will strengthen and continually improve company-wide level of internal and external quality.

• B.S. degree in Mechanical or Biomedical Engineering or similar technical field or equivalent
• A minimum of six (6) years relevant supervision experience
• Experience in biomedical engineering standards and concepts
• Experience working in cross-functional team environment and a multi-level corporate environment

• M.S. in Engineering or…