This is a remote position.
We are seeking aΒ Senior QA Engineer (Agile methodologies) to join our team.
Responsibilites:
- Lead Quality & Compliance Initiatives β Manage and validate QMS systems, automate software testing, and drive continuous quality improvements across our organization.
- Excellence in Quality Operations β Plan, execute, and refine processes and initiatives related to customer feedback, complaints, nonconformities, software defects, CAPAs, KPIs, and post-market surveillance.
- Collaborate Across Teams β Work closely with engineering, manufacturing and operations teams to ensure quality is embedded throughout our processes.
- Support Cutting-Edge Development β Contribute as a QA stakeholder in medical device software and instrument development, focusing on design controls and risk management.
- Champion Data-Driven Quality β 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 β 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:Β Remote
- 5 days working