PROCUREMENT MANAGER
Vilnius
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QUALITY SOFTWARE VALIDATION ENGINEER
2600-3400
€/mon.
Gross
Net per month
Vilnius
- UAB „Viltechmeda“
The Quality Software Validation Engineer provides design quality engineering support to the design and development group for software development and design changes in support of Moog's infusion and enteral feeding pumps sold both in the US and internationally. This individual will have a critical role in fostering overall quality and ensuring compliance with regulatory 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 including code review.
- 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's 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.
- Perform and/or support risk management activities.
- RA/QA representative on design reviews.
- Perform/Document audit, classify observations, review audit with audited.
- Other projects as assigned by management.
Here's what you'll need to be considered for this opportunity:
- Bachelor's degree in Engineering/ Computer Science/ Quality Assurance or a closely related discipline.
- QA or engineering/development experience in a regulated industry.
- Working knowledge of regulatory requirements and international standards such as FDA Quality System.
- Knowledge of Medical Device Directive and Regulation, ISO 13485, ISO 14971, IEC 62304 would be considered as beneficial.
- Knowledge in at least one of the following programming languages: C++, C#, Python.
- Software development experience would be considered beneficial.
- Experience in automated testing techniques and tools would be considered beneficial.
- Strong interpersonal and communication skills (technical, non-technical, and cross-cultural).
- Excellent knowledge of Lithuanian and English (both written and oral).
- 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.
- Understanding of risk management principles and practices.
- Experience in collection and analysis of quality metrics.
- Working knowledge of statistical methods.
In return Moog can offer you:
- The innovative environment of international companies.
- 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 working hours and possibility to work remotely.
Salary
2600-3400 €/mon. gross
Salary offer for the candidate depends on the level of competence and experience of the candidate.
Salary offer for the candidate depends on the level of competence and experience of the candidate.
UAB „Viltechmeda“
UAB “VILTECHMEDA”, global Moog Inc. Member of the group - since 1993, has been developing and manufacturing medical devices - infusion syringe pumps, supplying its products to Lithuanian medical institutions, and exporting to more than 80 countries around the world.
information about UAB „Viltechmeda“
144
Number of employees
10-20 mln. €
Revenue 2023 y.