Quality Engineer

vor 1 Monat

Zürich, Schweiz Nanoflex Robotics Project - Wyss Zurich Vollzeit

Job description

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. 

Your profile

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 

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