- Ensure site level compliance to appropriate ISO, FDA and other applicable regulatory standards.
- Drive strategies and methods to continuously improve consumable product quality performance.
- Establish clear and consistent quality measurement systems in order to monitor and drive results.
- Lead quality planning and the execution of assigned New Product (NPD) projects to achieve targeted quality deliverable adherence.
- Drive targeted supplier quality improvement efforts and oversees supplier evaluation, approval and control for assigned manufacturing sites.
- Assist in the continuous improvement and standardization of quality system procedures and monitor effectiveness.
- Support the reliability function by integrating design for reliability tools and techniques within the local projects.
- Lead quality planning efforts through cross-functional teaming at a site level.
- Support the New Product Development process and projects to ensure projects attain cost, quality and delivery objectives.
- Direct local staff on planning sequential and concurrent quality activities. Establish planning and monitoring tools and techniques.
- Provide Quality viewpoints and opinions in planning and specifying existing and future products.
- Assist in the development of the Quality budget. Help to ensures resources are adequate to fully support the Quality System.
- Take ownership of all local quality issues, projects and development activities.
- Work closely with the site’s Senior Management Teams to provide strategic direction and development of the manufacturing sites product quality strategies and tactics.
- A Bachelor's degree in Chemistry, Biology, Microbiology, Chemical Engineering or related technical degree required…Advanced degree preferred.
- 10 + years of experience with increased responsibility leading quality system and product quality improvement efforts.
- 8+ years of experience managing and leading high-performance teams.
- Multi-Site responsibilities.
- Regulated manufacturing industry experience, specifically Medical Device, Pharmaceutical or similar FDA, GMP, ISO 13485 regulated type product area.
Valid through: 9/1/2020