Plan, execute, and control company’s Quality Assurance system according to product specifications, quality and regulatory standards. Including identifying the technical requirements and ensuring that the technical solutions and manufacturing processes are compliant with the quality standards.
The focus of the position is to develop, perform and lead Quality Assurance related activities, which include the following:
· Maintaining procedures and quality management system up to date according to relevant standards for all company departments
· Supervise, and support the quality assurance activities in all different company departments
· Initiation and follow-up on Corrective & Preventive Action internally and with suppliers - CAPAs / SCARs.
· Follow up on all different QA activities in the departments
· Control and develop CA/PA process
· Development of the Total Quality Management System
· Write procedures and processes according to relevant standards
· Participate in internal and external audits
· New supplier evaluation, qualification and supplier quality audits execution
· Engineering changes review and approval related to production and new product instructions
· Review process validation protocols, support process verifications and validations, approve verification and validation reports.
- QA engineering graduate or engineering graduate with QA classes: B.Sc. or higher
· 4 years’ experience in QC and QA in Medical device industry
· Knowledge in European/CE and FDA regulations, including ISO13485
· Multitasked, independent, punctual and accurate with excellent organizational skills
· Team oriented, collaborative, good personal relationships
· Knowledge of quality engineering tools and statistical quality control techniques
· Knowledge of quality auditing techniques
· Knowledge of process validation techniques
· Language: English – fluent