Senior QA Engineer (Agile methodologies)
Senior QA Engineer (Agile methodologies)
Posted on :
28-05-2025
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1 Vacancy
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Job Description
This is a remote position.
We are seeking a Senior QA Engineer (Agile methodologies) to join our team.
Responsibilites:
- Lead Quality & Compliance Initiatives Manage and validate QMS systems automate software testing and drive continuous quality improvements across our organization.
- Excellence in Quality Operations Plan execute and refine processes and initiatives related to customer feedback complaints nonconformities software defects CAPAs KPIs and post-market surveillance.
- Collaborate Across Teams Work closely with engineering manufacturing and operations teams to ensure quality is embedded throughout our processes.
- Support Cutting-Edge Development Contribute as a QA stakeholder in medical device software and instrument development focusing on design controls and risk management.
- Champion Data-Driven Quality Leverage automation data analytics and process optimization to enhance our Quality Management System.
Requirements
- Proven experience in Quality Assurance within the Medical Device industry preferably in a leadership roles.
- Deep understanding of QMS principles and a track record of successful implementation.
- Strong background in risk management Agile methodologies and medical device development and/or manufacturing.
- Hands-on experience with automation data management and continuous improvement initiatives across various domains.
- Exceptional problem-solving analytical and communication skills especially important in our remote-first culture.
- A pragmatic product-focused mindset with in-depth understanding of medical device lifecycle.
- Knowledgeable in international regulations and standards such as EU MDR FDA QSR ISO 13485 IEC 62304 IEC 62366 and ISO 14971.
Benefits
- Work Location: Remote
- 5 days working
Proven experience in Quality Assurance within the Medical Device industry, preferably in a leadership roles. Deep understanding of QMS principles and a track record of successful implementation. Strong background in risk management, Agile methodologies, and medical device development and/or manufacturing. Hands-on experience with automation, data management, and continuous improvement initiatives across various domains. Exceptional problem-solving, analytical, and communication skills especially important in our remote-first culture. A pragmatic product-focused mindset, with in-depth understanding of medical device lifecycle. Knowledgeable in international regulations and standards such as EU MDR, FDA QSR, ISO 13485, IEC 62304, IEC 62366, and ISO 14971.
Employment Type
Full Time
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