ABOUT ABBOTT

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

EDUCATION & EXPERIENCE

• Minimum of 3 years relevant industry experience.
• A Primary Degree in Science or Manufacturing Engineering is required.
• Excellent communication skills to ensure effective engagement across multiple cultures.
• Clear capability to coach and develop cross functional leadership and promote teamwork.
• Clear demonstrated capability to develop and execute a strategic plan for future Quality , Operating and Regulatory system requirements.
• Strong ability to network across Abbott and to leverage Global support and expertise to support the plan development and execution.
• Excellent Stakeholder management capability.
• Has a history of completing successful projects and driving positive compliance outcomes.
  Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube

MAIN PURPOSE:

The Quality Engineer will lead and optimize our quality and compliance lifecycle with a focus on optimizing design transfer. This role is crucial in ensuring our International ID sites are consistently audit/inspection ready, conduct activities for design transfer optimally and meet the highest standards of compliance and quality.
The role acts to collaborate with cross-functional teams to drive optimization of our quality subsystem for design transfer and its related process, tracking progress and status, in an effort to ensure audit/inspection readiness.
The role requires the incumbent to benchmark across the ID functions and externally so as to determine and adopt best practices, ensuring we sustainably meet the requirements of applicable regulations and standards per RMDx’s Quality System.

MAIN RESPONSIBILITIES:

• Strategy Development and Execution: Lead the development and execution of assigned strategies to optimize our quality and compliance lifecycle, aligning with risk management and compliance objectives.
• Program Milestones Delivery: Ensure the delivery of quality and compliance lifecycle program milestones with respect to design transfer across International ID sites, maintaining audit/inspection readiness to meet required compliance and quality operating, process, and system standards.
• Workstream Oversight: Oversee assigned workstreams, planning and executing tasks to achieve the required standards.
• Process Optimization: Drive the optimization of sustainable quality and manufacturing processes relating to design transfer, implementing appropriate governance and metrics to ensure continuous compliance. Collaborate with pertaining peer functions in R&D, Design QA, Operations, Technical & Engineering.
• Benchmarking and Best Practices: Benchmark across ID sites and externally to identify and implement best practices for our quality subsystems and related processes, aiming for best-in-class compliant deployment.
• Communication and Reporting: Provide updates and escalate issues as needed to the ID steering team and senior leadership. Develop and deliver consistent communication plans on requirements and progress.
• Audit Support: Support both internally and externally led quality audits.