Manager Quality Engineering

Job Description Summary

The Manager Quality Engineering is responsible for the management, direction and coordination of all quality and regulatory compliance activities across the designated Columbus Manufacturing BU in compliance with world-wide regulations, business strategies, and customer needs. This includes providing the quality leadership encompassing Quality Systems, Quality Engineering, and Sterilization control to ensure that the required production, quality and regulatory standards are achieved through molding, assembly, packaging, sterilization and product release.

Reports to the site Associate Director Quality Management with dotted line reporting to the designated BU Manager.

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 Med Tech 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.

ESSENTIAL FUNCTIONS (RESPONSIBILITIES)

Essential functions include, but are not limited to, the following:

• Manages and leads the Quality Systems and Quality Engineering activities for the designated BU.
• Manages and support validation activities related to processes, products, materials and projects supporting the designated BU and other BUs when requested.
• Develops and implements strategic direction for the designated BU consistent with Hypodermic Platform, MDS and BDX Quality strategy.
• Provides effective Quality Management leadership to designated BU BLT and contributes to the Columbus Quality leadership Team in order to meet quality, business and organizational objectives of the BD Medical:
  Medication Delivery Solutions.
• Provides effective leadership in teamwork development, effective communication and quick responses to customers.
  
  Drives improvements towards customer centricity.
• Implements effective CAPA process focused on reduction of causes of customer complaints, non-conformances, excursions, rejections and waste.
• Assesses and builds organizational capability for Quality management, particularly in the selection and mentoring of dedicated high caliber QEs and QC Reps (Quality Engineering and Quality Representatives) professionals.
• Evaluates, facilitates, designs, implements and continually improves quality systems and business processes, including product controls to achieve quality goals and to maintain a high level of regulatory compliance.
• Management representative for the designated BU with regards to all Quality System regulation issues.
• Enhances BD Columbus designated BU management’s understanding and application of broad scope Quality Management principles through education, training, and workshops.
• Provides leadership and guidance in integrating Quality Management and continuous improvement into the Columbus business strategic planning process.
• Champions the needs of both internal & external customers by factoring these needs into planning & decisions at all levels.
• Builds a strong interactive working and strategic relationship with appropriate designated Platform Quality, R&D and Regulatory management groups.
• Builds & sustains a Columbus business culture that accepts Excellence as an expectation, compliance as an outcome and goal.
• Provides coaching, and facilitation support to all levels at the designated BU Columbus plant.
• Interfaces with Regulatory Agencies (FDA, ISO notified body, other foreign regulatory bodies).
• Leads and supports customer audits, internal audits.
• Recommends and implements necessary actions and programs to continually upgrade the Quality Management/Quality System/Quality Engineering capability of the designated BU.
• Engage and deploy zero customer complaints program.
• Support the designated BU to meet: CPM,…