Support the use and maintenance of the quality management system and ensure that the company follows Medical Device Quality Management System requirements, standards and regulations.
Update Quality system and production procedures and specifications
Responsible for trainings as well as employees’ qualification records
Approves new equipment, changes to equipment and equipment validation
Handling Non-conforming process, MRB
Handling customer complaints, including reportable assessment and investigation
Leads Supplier evaluation and approval
Support Internal/external Audit. Able to record Audit observations and prepare and/or review written QA reports for audits and inspections
Identify and help facilitate continuous improvement, corrective and preventive actions (CAPA).
Interface with other departments as necessary
Ensure that production and packaging operations are performed according to procedures
Bachelors’ degree in Science or Engineering OR practical Engineer with Quality certificate
Minimum 2- 3 years related experience in a regulated environment, preferably Class 3 medical devices/ pharma.
Knowledge of ISO13485:2016, ISO 14971 and 21 CFR Part 820 quality systems is required
Be able to handle multiple projects
Ability to work independently
A team player
Strong skills in organization, accuracy, attention to detail and interpreting analytical data.