Product Quality Assurance Analyst, Temp

at  Abbott Laboratories

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.

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

• 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