Sr. QA Specialist
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
Career development with an international company where you can grow the career you dream of.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works at Istanbul location in the Diabetes Division that we’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
What You’ll Do
1. Primary Objective of Position
Supports the implementation of an effective ADC Commercial / MIMS Quality System for ADC EMEAP Commercial Affiliates according to Abbott Internal and External Regulatory Requirements.Supports the maintenance of the Quality System (QS) compliance and respective processes across the ADC EMEAP Countries in collaboration with the Subject Matter Expert (SME).2. Major Accountabilities
Contributes to the implementation and maintenance of an effective ADC EMEAP Quality System / Multisite Integrated Management System (MIMS) by taking responsibility for:Supports/ prepares/ coordinates internal and external audits.Supports Affiliate Quality System processes: e.g. management reviews, supplier / warehouse / distributor control, CAPA, Field Action, Quality Hold, Ad/Promo, document control and record keeping.Establishes / implements ADC/MIMS and local quality procedures according to internal and external regulatory standards.Monitors and tracks Affiliate QS activities.Supports QS training programs to ensure all relevant employees are trained and records maintained.Ensures that all activities are performed in compliance with applicable quality system and (local) regulatory requirements.Supports medical event reporting, and field actions in close cooperation with Global ComQA, Customer Service, Regulatory Affairs and Vigilance/ MEG.Supports commercial organization regarding quality matters, e.g. launch/commercial projects (e.g. incl. contracts, tenders, external partnerships, …).Supports or leads Quality System improvements and implementation projects, e.g.: Champions/ SME program.Required Qualifications
Bachelor’s degree with Scientific / Technical background is preferred (e.g. Lab Technician, Biology, Chemistry, Pharma, Life Science, Engineering) or closely related discipline.Preferably 2-3 year of experience in Quality of Medical Device, Diagnostic or Pharma Industry (Commercial, Manufacturing or R&D Operations)/ Clinical Laboratory/ Competent Authority/ Industry Association, etc. or related experience.Experience in handling/ supporting QS elements such as CAPA, Supplier Management, Product Issue Handling etc. is preferred.Has a basic knowledge of international quality systems and medical device standards, such as ISO 13485, ISO 9001, etc.Fluent English skills, both verbal and written.Strong proficiency in using personal computer and business/technical software (e.g., Microsoft Office).Experience to work in international environment/ projects is preferred.Apply Now
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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