Manager, Quality Engineering ( Full-time ) Columbus, NE DK

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 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 managements 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.