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, Financial goals, Waste target, CI projects, Deliveries, Zero past due CAPA, BBQ, 5S.

• Other duties, as assigned.

REQUIREMENTS:

• Bachelor of Science degree in Engineering or Science related field.

• Minimum 5 years’ experience in quality, with a minimum of 3 years in the medical device industry

• Experience with Validations, CAPA, Statistical Analysis.

• Experience with high volume manufacturing processes.

• Experience in Lean/Six Sigma.

• Experience managing and leading people required.

• Experience communicating with all levels of the organization.

• Capable to manage under pressure and set priorities accordingly.

• Full support to a 24/7 operation.