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.
Security Clearance Required: No
Visa Candidate Considered: No
CompensationBase Salary - USD $120,000 to $135,000
