Product Quality Assurance Manager
2000-2500 €/mon.
gross
CVbankas.lt calculator data.
Full-time
Nature of work
- Prepare, maintain and periodically update technical documentation for medical devices, ensuring its compliance with applicable regulatory and standard requirements;
- Perform quality assurance and regulatory compliance activities in accordance with ISO 13485, Regulation (EU) 2017/745 (EU MDR), UK Medical Devices Regulations 2002 (UK MDR) and other requirements applicable to the company;
- Prepare analyses of regulatory requirements, standards and other changes related to product compliance, assess their impact on products, processes and technical documentation;
- Participate in quality management system activities - prepare and update documents, participate in the management of audits, changes, non-conformities, complaints, risks and improvement activities;
- Prepare and update documentation for clinical and biological evaluation of products, perform scientific literature search and analysis;
- Participate in new product development projects and changes to existing products, and prepare related quality and regulatory documentation.
Employee requirements
- Higher education in natural sciences, chemistry, engineering, medicine or dentistry;
- Experience in the field of quality assurance, regulatory compliance and/or preparation of technical documentation for medical devices;
- Knowledge of Regulation (EU) 2017/745 (EU MDR) and other standards applicable to medical devices;
- Experience in preparing clinical and/or biological evaluation documentation in accordance with the MDR and ISO 10993 series of standards is a great advantage;
- Knowledge of dental materials and/or clinical procedures in dentistry is a great advantage;
- Ability to analyze regulatory, technical and scientific information, systematize it and prepare substantiated conclusions;
- Excellent written and oral knowledge of English - technical documentation is prepared in English;
- Diligence, responsibility, independence and the ability to manage several tasks simultaneously.
The company offers
- Interesting and responsible work in the field of quality assurance and regulatory compliance of medical devices;
- The opportunity to work with ISO 13485, EU MDR and UK MDR requirements and diverse technical documentation of medical devices;
- The opportunity to deepen professional knowledge and grow in the field of QA/RA;
- The company's employee incentive and support system;
- Health insurance;
- 24/7 accident insurance;
- A hybrid work model - the opportunity to work remotely 2 days a week.
Health
Health insuranceSalary
2000-2500
€/mon.
gross
The specific salary is offered taking into account work experience, competence and compliance with other requirements of the position.
The specific salary is offered taking into account work experience, competence and compliance with other requirements of the position.
Work place
UAB „Medicinos linija“
A successfully operating company producing innovative dental materials is looking for a new team member in Šiauliai - a product quality assurance manager.
See all ads of this company (2)
UAB „Medicinos linija“ information
2620 €
Avg. salary gross
(21% higher than LT average)
68
Number of employees
3-5 mln. €
Revenue 2025 y.
Distribution of employees by salary (before taxes):
25% earn up to
1737 €
25% earn
1737-2149 €
25% earn
2149-3334 €
25% earn more than
3334 €