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Product Quality Assurance Analyst
3 months ago
The Opportunity
The position of Product Quality Assurance Analyst is within our Cardiometabolic and Informatics Business Unit located in Oslo, Norway. This role has frontline communications with established intake sites. In this role you will quickly and accurately ascertain all available information associated with complaints, conduct analysis and follow up on activities associated with these complaints. You will work independently and in a team environment in order to ensure complaints are analyzed and closed in accordance with established procedures.
What You'll Do:
Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
Main responsibility is review, evaluate, investigate and close complaints, incl. escalate potential reportable events for evaluation of reportability
Respond to inquiries regarding ATN products from customers and employees in other parts of the company
Perform customer data analysis to identify product and market related trends as part of requested complaint searches, e.g. as part of CAPA investigations
Prepare procedures that ensure good work processes in the department and that systems and documentation meet the requirements of GMP, ISO13485, and other relevant standards and regulatory requirements
Qualifications:
Bachelor’s degree in natural sciences or equivalent technical discipline, and 2-5 years of relevant experience
Lack of appropriate education level can be replaced / supplemented by 3 years experience in related fields
Preferred qualifications:
Experience in complaint administration
Experience from work with quality assurance, production and/or quality control according to GMP / ISO 13485 requirements
Knowledge of diagnostics products’ technology, applications and expected performance
Personal competencies:
Good communication skills in Norwegian and English; in writing, reading and speaking.
Good ability to take initiative and work independently.
Good ability to analyze, and understand the customers’ needs
Good documentation skills
Precise and systematic
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 parents, female executives, and scientists.
