Quality Engineer
Nanoflex Robotics is a startup, deep tech, medical company that has spun out of ETHZ, Zurich Technical University and founded in October 2021. We are supported by the Wyss Zurich foundation, grants and private funding. We aim to bring our robotic technology, initially for the remote treatment of stroke, to market. Nanoflex Robotics is reinventing remote robotic surgery to make life-saving interventions accessible to everyone.
Through innovation our novel core technology around the ability to operate medical devices inside the body through the control and manipulation of electromagnetic fields and the ability to “pull” devices through endoluminal spaces rather than push them. This set of technologies is unique within the medical device market and we think this is the basis for a strong and successful medical device company.
Companies come and go, but our dedication to rapid innovation and team collaboration is gaining us substantial attention and propelling us towards becoming a potential world leader in our industry. At Nanoflex Robotics, we’re seeking an experienced quality engineer to build upon this foundation. The ideal candidate is an exceptionally organized, methodical professional who has the experience necessary to take our products to the next level of accuracy, security, and safety. This person will be responsible for developing a complete QA program that not only safeguards the quality of our products, but also fosters a company culture in which all employees are actively engaged in guaranteeing it.
You should have excellent professional English writing skills to be able to proof-read and refine some of the language needed for our submissions. You will have an in-depth knowledge of the medical device requirements and keep up to date with the latest developments. The candidate is expected to be involved, engaged, respectful and proactive. Key for success in this position will be the ability to fulfill regulatory requirements and maintain flexibility and adaptability in our processes to support our entrepreneurial culture and pace. Therefore, understanding the needs of employees from other functions, particularly within product development, is essential. Equally important is also a solution-oriented, flexible, and empathetic mindset while taking ownership and delivering on what they promise.
Key areas of responsibility
Objectives of this role
- Interpret, develop, build upon, and comply with the company's quality assurance standards
- Maintain the complaint, nonconformity, and corrective action processes using records and tracking systems, including root-cause analysis
- Document quality assurance activities with internal reporting and audits
- Develop new standards for production and design, with improvements as needed, and create inspection/testing protocols for production
- Identify training needs and ensure companywide participation
- Pursue continuing education in new solutions, technologies, and skills
Responsibilities
- Plan, execute, and oversee inspection and testing of products to verify conformance with specifications and deliverables
- Assist operations team in tracking, documenting, and reporting quality levels for CSR (corporate social responsibility), and goals/KPIs
- Investigate product complaints and reported quality issues to ensure closure in accordance with company guidelines and external regulatory requirements
- Develop or update company complaint and inspection procedures to ensure capture, investigation, and proper documentation
- Monitor risk-management procedures, and use problem logs to identify and report recurring issues to management and product development teams
- Provide training and support to quality assurance team members, focusing on systems, policies, procedures, and core processes
- Keep up-to-date with the current regulatory environment (Medical Devices).
- Work as part of a multidisciplinary team in the development of medical devices.
- Implement improvements to the quality management system.
- Host and coordinate quality and regulatory audits (internal/external).
- Measure and report performance of critical processes to executive management.
- Be part of the team, help create the company and the company culture, build on your experience to help educate our team.
- Speak up when things are going wrong and speak up when things are going well.
Skills and Qualifications
- Deep knowledge of quality assurance terminology, methods, and tools
- Excellent analytical, problem-solving, and decision-making skills
- Demonstrated knowledge of testing best practices, version-control procedures, and defect management processes
- Excellent computer proficiency, including document control
- Bachelor’s degree (or equivalent) in science, engineering or related field
- Ability to communicate in more than one language
- Training opportunities
- Perspectives for career development
- Support programmes (e.g. mentoring) and networks
- Your (team) culture and team composition
- Working environment and employment conditions
- Your commitment to diversity (e.g. flexible working hours, possibility for part-time work, home office)
We look forward to receiving your online application with the following documents:
- Cover Letter
- CV
- Diplomas and reference letters
Please note that we exclusively accept applications submitted through our online application portal. Applications via email or postal services will not be considered.
Further information about Nanoflex can be found on our website. Questions regarding the position should be directed to Chanel Allen-Megahey, Write an email, or email Goran Vucinic, Write an email (no applications).
For recruitment services the GTC of ETH Zurich apply.
Adresse
ETH Zürich
