What are the responsibilities and job description for the IVDR Tech Leader position at Abbott Laboratories?
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 113,000 colleagues serve people in more than 160 countries.
About Abbott Diagnostics
The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.
Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.
Our Core Lab Diagnostics team currently has an opportunity for an IVDR Tech Leader who can work out of our Lake County, IL, Irving, TX or Sligo, Ireland locations. This new team member will have a broad understanding of Diagnostics Industry including Supply Chain activities, Manufacturing Operations, Design Transfer, Quality/Regulatory Registrations, Customer Expectations. The ideal candidate will provide direction, leadership and management of all scientific/technical deliverables necessary to transition products manufactured by Third Party Manufacturers (TPMs) from IVD-Directive to IVD-Regulation compliance. The Technical Leader will accomplish goals related to evaluation and remediation of technical documentation including Design Plan deliverables, labeling changes, risk management updates, technical file content, product performance (analytical and clinical) and post-market surveillance. Additionally, will accomplish operations goals necessary for full implementation of IVD-R complaint products in all applicable countries and actively supports continuous product availability and integration of IVDR project with other ADD programs. The successful candidate will foster continuous improvement and actively support the personal and professional development of individuals as well as act as a liaison to program and operations management, ADD sites, and TPMs. They will be accountable for internal/external customer satisfaction and plan and manage financial, and human resource needs.
WHAT YOU’LL DO
Responsible for implementing and maintaining the effectiveness of the quality system.
Leads/facilitates problem solving within team and across functional areas.
Ability to work directly with customers for technical issues with enhanced technical understanding across clinical utilities, able to problem solve across the entire supply chain and distribution.
Identify and Drive Product Improvements through-out product portfolio life cycles that focus on customer and industry performance improvements and gross margin improvements.
Apply Risk Management across entire product life cycles.
Supports product availability through management of investigations and completion of technical projects. Provides any needed support to manufacturing and testing areas.
Demonstrates an understanding and appropriate application of basic problem-solving models and tools.
Analyzes trend data from a variety of sources.
Facilitates determination of root causes and develops plans to resolve problems. Anticipates and avoids reoccurrences.
Prioritizes and allocates resources to ensure timely resolution.
Facilitates maintenance of documents such as DHF, VMP, and FMEA to ensure product knowledge/history is maintained.
Acts as a liaison to management and associated functional groups.
Makes timely scientific, operational, and business decisions. Appropriately elevates high-risk decisions.
Cultivates relationships with internal and external customers and develops strong networks throughout the company and industry.
Identifies personal and professional development objectives and plans to achieve them.
EDUCATION AND EXPERIENCE YOU’LL BRING
Required
Bachelor's degree required in a scientific / technical discipline plus 10 years’ experience in a related scientific / technical field. Advanced degree(s) may offset required years of experience.
Minimum of 10 years’ experience in a related scientific / technical field. Advanced degree(s) may offset required years of experience.
Preferred
Masters or PhD
Experience includes leading others at multiple levels in project management, product development/ launch / on-market leadership, crisis management, customer interactions; proven ability to develop others; knowledge and understanding of business metrics. Experience includes multiple functions (R&D, TPD, QA, OPs, etc.), products, and/or platforms; experience with resource planning, budgetary management, and personnel administration
Strong Leadership and collaboration skills
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
Training and career development, with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal