Strefa Klienta
Our client is a medical device company focusing on the development of treatment solutions for liver diseases and heart failures.
What's on Offer
We offer a challenging opportunity within an international corporation with the possibility to develop both personally and professionally. Are you the candidate we are looking for? Feel free to reach out to me in case of any questions. I am looking forward to your application.
Job Description
- Management of all tasks with respect to the verification and validation activities (e.g. validation of software, processes, products, equipment etc.) as well as all associated revalidation activities
- Responsible to generate, review, edit and approve qualification and validation / revalidation protocols, process specifications, FMEAs, test plans and summary reports as well as other associated documents to allow conformance to regulations and standards
- Responsible to generate, review, edit and approve, SOPs, CAPAs, and other applicable documentation as part of the identified tasks during the verification and validation activities
- Responsible to analyze testing results using statistical techniques and determining acceptability
- Responsible to investigate and troubleshoot problems identified during and associated to verification and validation activities and to determine solutions or recommendations for changes and/or improvements
- Responsible for the validation of software used within the quality management system (e.g. software controlled test equipment used during in-process inspection)
- Support the change control proves of SOPs and other applicable documents
- Support the preparation and update of the respective KPIs and management reports
- Lead cross-functional teams to plan and facilitate Qualification/Validation activities within the organization
- Responsible to cover the QA area while vacation
The Successful Applicant
- Technical Bachelor`s Degree in a related field, Master's Degree an advantage
- At least four years of experience within the field of medical device verification and validation
- Experience in Quality Assurance activities/techniques
- Strong technical expertise when reviewing and approving validation protocols, process specifications, FMEAs, test plans and summary reports and other verification and validation related documents
- Experience in FDA/ GMP/ QSR /ISO13485 and within statistical techniques
- Proven leadership qualities, including making decisions to meet the goals set and leading effective meetings
- Ability to develop a "hands-on" approach, requiring personal initiative, reliability and responsibility while operating at a high level of performance and efficiency maintaining confidentiality and meeting deadlines
- Strong written and verbal communication skills, including report writing
- Fluency in English is required, additional languages (e.g. German) would be beneficial
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