Lead Quality Assurance Specialist
1 week ago
Position Overview
The role of Quality Assurance Program Manager is essential for ensuring compliance and excellence within Abbott's operational framework. This position focuses on managing external audits and inspections related to Abbott's Quality Management System, providing strategic leadership and project oversight across various business units.
In this capacity, you will be responsible for guiding the organization through pre-audit preparations, supporting teams during audits, and facilitating follow-up actions post-audit.
Key Responsibilities
- Develop and implement a comprehensive Inspection Readiness Strategy across Abbott.
- Collaborate with different business units to ensure thorough preparation and effective management of third-party audits.
- Offer expert guidance during audits, including identifying potential issues, facilitating the audit process, and delivering training.
- Evaluate compliance levels and the effectiveness of management teams in meeting quality standards.
- Coordinate project timelines and deliverables for various sub-teams involved in quality assurance.
- Analyze critical topics and propose risk-based solutions to enhance compliance.
- Stay informed about new regulations that may affect Abbott's operations.
Qualifications
- Bachelor's degree in a scientific or related field.
- Four-year degree in a technical or scientific discipline.
- Proven experience with regulatory audits and inspections.
- Solid understanding of quality management systems and regulatory compliance.
Preferred Qualifications
- Ability to act as a Technical Advisor or Subject Matter Expert.
- Strong communication skills with executive leadership on quality initiatives.
- Experience in managing inspections and understanding regulatory frameworks.
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