BD is looking to solve quality and regulatory compliance issues across its Columbus Manufacturing BU, ensuring production, quality, and regulatory standards are met.
Requirements
- Experience with Validations, CAPA, Statistical Analysis.
- Experience with high volume manufacturing processes.
- Experience in Lean/Six Sigma.
- Experience managing and leading people.
- Experience communicating with all levels of the organization.
- Capable to manage under pressure and set priorities accordingly.
- Full support to a 24/7 operation.
Responsibilities
- 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.
- Implements effective CAPA process focused on reduction of causes of customer complaints, non-conformances, excursions, rejections and waste.
- 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.
- Interfaces with Regulatory Agencies (FDA, ISO notified body, other foreign regulatory bodies).
Other
- 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
- Minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations
- Employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19.
- Paid parental leave up to 6 weeks
