Senior Quality Assurance Engineer

• Maintaining the quality system
• Handling customer complaints
• Approval of DMR (Device Master Record) for new products
• Prepare inputs for management review including quality data analysis / trends
• Prepare, implement and maintain quality procedures
• Define and maintain the quality infrastructure in the company
• Handle nonconforming products / materials, and corrective and preventive actions
• Assess the quality procedure effectiveness by planning and conducting Internal Quality Audits
• Approve sub-contractors/suppliers
• Control of documentation and quality records
• Control of equipment calibration and maintenance
• Support Design and Development processes, including design transfer and design change
• Support risk management process
• Support improvement process
• Overall responsibility for QC inspections of raw materials and finished goods

Authorities:

• Approval of qualification and validation activities
• Defines the quality policy (together with VP QA and controls its implementation
• Control of processes in compliance with the applicable QA procedures
• Create and realize quality plans
• Sub-contractors and suppliers' approval and audits
• Lot Release / product release
• Training and qualifying the company employees
• Leading quality audits by regulatory authorities

Experience Requirements

At least 6 years’ experience in implementing and managing quality management system according to ISO13485 and FDA QSR

At least 6 years’ experience with implantable devices, preferable active implantable devices

Knowledge of the MDR, 93/42/EEC MDD and AIMD 90/385/EEC requirements

Experience in quality audits by Notified bodies

Relevant experience and knowledge with the Risk Management process according to ISO 14971

Previous experience with medical device SW/device which combines SW

Previous experience with biocompatibility testing (ISO 10993 requirements)

Previous experience and knowledge with the ETO sterilization process

Previous experience with production processes and good knowledge with DMR maintenance.