In this senior role, you drive the transfer of new and modified products from R&D to manufacturing, enabling Abbott Diabetes Care to scale support for millions of customers. You will align Quality, Operations, Engineering, Regulatory, and R&D to ensure compliant, efficient transitions from development to production. You’ll lead validation strategies and risk management to safeguard product quality across global sites and partners. This position offers strategic influence on manufacturing readiness and how innovative diabetes technologies reach patients. You’ll work in a fast-paced, globally distributed environment with a strong focus on compliance and continuous improvement.
Pay / Benefits
competitive salary
bonus opportunity
defined benefit pension
private healthcare
life assurance
flexible benefits
Responsibilities
Lead strategy, planning and execution of design transfer activities for new products, changes and manufacturing improvements
Drive commercialization of diabetes care technologies from development into global manufacturing operations
Collaborate with cross-functional and cross-site stakeholders to ensure successful product launches and business continuity
Ensure compliance with Abbott Quality Systems and regulatory requirements (FDA, ISO)
Support site selection and onboarding for product transfers (Abbott and external)
Lead validation strategies (process, test method, manufacturing qualification)
Drive continuous improvement to enhance quality, operational performance and regulatory compliance
Provide leadership, coaching, and technical guidance across quality engineering and project teams
Act as SME during regulatory inspections and quality audits
Manage risk using DFMEA, PFMEA, Fault Tree Analysis and other methods
Key requirements
Bachelor's degree in a scientific, engineering or related discipline
Progressive experience in the medical device industry
Leadership or management experience
Strong knowledge of medical device regulations and quality systems (FDA, ISO 13485) and risk management principles
Extensive experience in product development lifecycles, design controls, design transfer, process validation and change management
Proven leadership of complex cross-functional projects across multiple sites
Understanding of manufacturing processes, quality systems and product commercialization
Excellent communication and stakeholder management skills
Ability to influence across levels in a fast-paced global environment
Experience with contract manufacturers and global supply chains (advantageous)
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