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- Details
- Highlights
- Company
The Software Validation Quality Engineer provides design quality engineering support to the design and development group for software development and design changes in support of Moogs infusion and enteral feeding pumps sold both in the US and internationally. This individual will have a supportive role in fostering overall quality and ensuring compliance with requirements and international standards with respect to quality system, manufacturing, and medical device software.
Your responsibilities would be:
- Approve and support design, software and processes verification and validation protocols.
- Review and support compliance for quality systems requirements.
- Identify compliance gaps and work with Engineering team to resolve compliance issues.
- Identify improvement opportunities within the company Quality Management System (QMS).
- Support cross-functional projects to improve and maintain compliant, effective and efficient quality processes.
- Maintain up-to-date knowledge of regulatory requirements, international standards, and company QMS procedures for areas of responsibility.
- Support risk management activities.
- RA/QA representative on design reviews.
Here's what you'll need to be considered for this opportunity:
- Bachelors degree in Engineering/ Computer Science/ Quality Assurance or a closely related discipline.
- QA or software validation/testing experience.
- Working knowledge of regulatory requirements and international standards.
- Knowledge of Medical Device Directive and Regulation, ISO 13485, ISO 14971, IEC 62304 would be considered as beneficial.
- Experience in testing techniques and tools would be considered as beneficial.
- Excellent knowledge of Lithuanian and English (both written and oral).
- Understanding of risk management principles and practices.
- Experience in collection and analysis of quality metrics would be considered as beneficial.
- Attention to details and ability to consistently meet high standards of quality.
- Good organization and time-management skills, and ability to work simultaneously on multiple projects.
- Proficiency using Microsoft Office tools: Word, Excel, Power Point and Outlook.
In return Moog can offer you:
- The innovative environment of international company.
- Supportive, friendly working culture and possibility to have a real impact with your work.
- Be a part of our international team, which is located cross-borders in Vilnius, USA, Costa Rica.
- The possibility to do something meaningful: working with medical devices you will contribute in -saving lives around the globe.
- 22 days annual leave.
- Insurance against accidents.
- Annual Profit Share program.
- Flexible work hours.
€
3000 - 3700
Additional information: Salary offer for the candidate depends on the level of competence and experience of the candidate.
Location
- Vilnius, Vilniaus apskritis, Lithuania
Mokslininkų g. 6
Time of work
- Full-time
- Flexible schedule
Skills
Languages
- English
- Lithuanian
Contact person
Agnė Bandzienė
Agnė Bandzienė
Viltechmeda UAB is a designer, manufacturer and distributor of high precision medical equipment infusion pumps and enteral pumps. Established in 1993 we export our products to more than 80 countries worldwide. Since 2009, Viltechmeda is a member of Moog Inc.
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