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.
Requirements
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.
Company Description:
Employer
A growth-oriented, privately-held, family-owned, manufacturing organization.
A manufacturer that makes a wide variety of steel products and caters to a diverse group of industries.
The company in the process of opening a new plant.
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