Abbott is seeking a Manager Quality Assurance II (Design Quality) to provide leadership, oversight, and project management covering new product development and on-market design changes as related to Abbott's Quality System for assays and commodity/consumables for the Alinity s platform and any future TM platforms.
Requirements
- Bachelor's Degree preferred in a technical/scientific discipline or closely related field.
- 6 - 10 years experience preferably in a quality/ technical area or clinical laboratory.
- Demonstrated leadership experience through formal and/or informal assignments is preferred.
- Knowledge of regulations and standards affecting IVDs and Biologics.
- Sound fundamental understanding of regulatory inspections and quality systems.
- Ability to serve as a Quality Advisor, Consultant, or Subject Matter Expert including: Design Quality and Design planning including assay development, stage gate process (product life cycle) and deliverables.
- Proven technical capabilities covering serology, NAT, and commodity/consumable technology.
Responsibilities
- Provide design quality leadership and direction for new product development and on-market design changes of Transfusion Medicine assays and commodities following the Core Dx Quality System.
- Direct reports include 6-9 individuals. Indirect reports include 2-6 individuals.
- Build and maintain a strategic work force while mentoring direct reports and providing growth opportunities to support talent management pipeline.
- Participate and/or lead Quality Plan Projects/Quality Project focused on quality system and GMI initiative. Provide direct business/division support. Participate in new and change regulation review for business impact.
- Engage and interaction with senior leadership and key stakeholders across the division and accountability for assigned projects.
- Work collaboratively with peers throughout TM R&D, Operations, Regulatory, PMO, Commercial, Finance, etc.
- Provide support, consultation and direct interface during internal and third-party inspections including the identification and review of outstanding issues/potential audit risks, mock audit training, and promoting effective and professional inspection readiness activities.
Other
- Travel: Yes, 5 % of the Time
- Medical Surveillance: Not Applicable
- Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Routine work with chemicals, Work requiring repeated bending, stooping, squatting or kneeling
- Degree Requirements: Bachelor's Degree preferred
- Work Shift: Standard
