Quality Assurance Administrator
Description:
The quality assurance administrator collects, reviews and analyzes data to ensure efficiency of quality assurance procedures.
Key Roles and Responsibilities:
▪ Work within the ISO 13485 Quality Management System
▪ Audit preparation and audit participation
▪ Oversee QC of raw materials, in-process and completed products
▪ Review of production and QC records before products are passed for use
▪ Packaging inspections, assistance with QC inspections and testing when required
▪ Identify and implement opportunities for improvement to the Quality Management System
▪ Participate in data gathering and analysis of statistics
▪ Drive document control and storage in conjunction with QA&RA Manager
▪ Continuous promotion of quality awareness and management system requirements among all staff
▪ Writing and/or updating of reports, protocols, procedures, work instructions, data cards and forms
▪ Initiate change controls, customer complaints, corrective actions, supplier NC’s, TI’s, DC’s
▪ Monitor status of TIs, NCs, CAPAs, DCs and ensure these are closed off timeously
▪ Participate in regulatory affairs to learn about regulatory systems
▪ Supplier management (questionnaires, evaluations, agreements, certificates, risk profiles, etc)
▪ Capture all training registers and update skills matrix accordingly
▪ Administration of Quality Management System
▪ Any other ad hoc quality related tasks that may arise
▪ Perform any reasonable duties as requested by Management, including duties outside of the department, in order to contribute to the functioning of the company.
Knowledge, Skills and Experience Required
▪ Knowledge of ISO 9001/ISO 13485 would be advantageous
▪ Excellent oral and written communication capabilities
▪ Report writing abilities
▪ Experience with audits would be beneficial
▪ Exceptional attention to detail
▪ Computer skills (Proficient in Microsoft Word, Excel and Adobe Acrobat)
▪ Time management skills
▪ Ability to work independently