- Provide Quality Assurance oversight for SiMD and SaMD software development, employing Agile and waterfall methodologies
- Resolve key issues, act as a liaison between project teams and Quality organization, ensuring compliance
- Review Computerized System Validation of software tools
- Contribute to revisions of software procedures (SOPs)
- Support Quality system activities, including supplier evaluations, software audits, and complaint investigations
- Collaborate with global R&D and QA teams
- At least a bachelor's degree or significant equivalent professional experience
- Fluency in English, good command of German
- 5+ years of relevant experience in FDA/ISO-regulated medical device software development
- Strong interpersonal and communication skills for virtual, remote, and asynchronous work environments
- You will get a competitive salary & benefit package
- You will work in a welcoming and inclusive environment with highly qualified colleagues at a market-leading multinational company in Erlangen /Teltow
- You can contribute to the quality and compliance of innovative medical software solutions
Software Quality Engineer – medical devices - Erlangen, Deutschland - D105 WaveLight GmbH Company
Beschreibung
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.
WaveLight GmbH is a global leader in developing and producing innovative laser systems for use in eye surgery . Since 2009, WaveLight has been a wholly-owned subsidiary of Alcon, enabling gentle and highly precise correction of vision impairment.
We are currently seeking a skilled Software Quality Engineer (m/w/d) to provide oversight for Software in a medical device (SiMD) and Software as a medical device (SaMD), supporting our Quality Assurance organization and acting as the core team lead for Software Quality. You will collaborate with global teams and contribute to innovative medical software solutions, ensuring compliance with WaveLight/Alcon procedures and regulatory standards.
In this role, a typical day will include:
WHAT YOU'LL BRING TO ALCON:
HOW YOU CAN THRIVE AT ALCON:
Take your chance and apply directly online with your CV (English version)