The main responsibility of Quality Manager is to lead the quality function, assure documented system in place to guarantee compliance of product with customer requirement, product specifications and other regulations, drive continuous improvement activities.
- Implement and maintain the Quality Management System according to ISO 13485 standard.
- Ensure that processes needed for the quality management system are documented.
- Train the personnel of quality and environmental awareness, quality and environmental systems and customer requirements.
- Conduct and lead internal/external and unannounced audits.
- Control of management of non-conforming product.
- Report to top management on the effectiveness of the quality management system and any need for improvement, prepare Management review.
- Responsible for monitoring of quality indicators (quality KPIs) and development of quality KPI measurements, setting the targets and monitoring the performance.
- University degree with specialization of medicine industry/law or equivalent.
- 3 years’ experience in similar role in manufacturing medical devices industry considered as advantage.
- Very good knowledge and experience of quality standards (ISO13485 or ISO9001).
- Good knowledge of Continuous Improvement processes in manufacturing environment.
- Ability to plan and organize capacity and resources and adapt them if needed.
- Ability to work under time pressure and deliver on multiple priorities simultaneously.
- Very good leadership, communication, co-operation and negotiation skills.
- Very good level of written and spoken English.
- Competitive salary.
- Opportunities for professional growth and development.
- Challenging and interesting work in an international environment.
1100 m² production site is located within the European Union (TRATE UAB) and running 24/7 with over 70 employees which carry out: machining on Swiss-type lathes, washing and disinfection, clean room packaging, design & developing, surface finishing, quality control.