Director, Quality Assurance - Abbott Vascular

Ensures Design Control activities are robust in ensuring the highest quality and reliability of products from concept through manufacturing. Ensures that development products have the appropriate characterization and validation data to demonstrate that business objectives have been met, prior to formal transfer to manufacturing.

• Recruits, coaches and develops organizational talent.
• Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, BSI regulations, etc.).
• Recommends and implements changes to the Quality System as the result of changing regulations, continuous improvement and/or business needs.
• Ensures rigorous and diligent Design Control practices, including data-driven stage-gate reviews, robust characterization and validation, and stakeholder-focused success criteria for all stages, including manufacturing transfer and commercial readiness
• Ensures that appropriate specifications are assigned for materials, process parameters, in-process and finished good testing, etc, and that these specifications are justified with appropriate characterization and validation data.
• Demonstrates strong product knowledge, problem solving, change management, results orientation, and data-driven decision making.
• Builds strategic partnerships with internal stakeholders, including operations, regulatory affairs, R&D, clinical, operations QA, and ensures alignment of goals and critical success factors for product development, approval, and manufacturing needs.
• Interacts internally and externally with executive level management, outside regulatory agencies, customers, vendors and/or suppliers.

• Bachelor's degree required in a related field or a equivalent combination of education and work experience
• Master's degree preferred
• Minimum 12 years of relevant career experience required

• 401k matching
• Health insurance
• FreeU education benefit
• Freedom 2 Save student debt program