Quality Specialist

Quality Specialist

Quality Specialist

80%-100%, Zurich, fixed-term

At the MYNERVA project - a Wyss Zurich project- our mission is to improve the life of patients suffering with diabetic neuropathy.

MYNERVA developed a medical device to artificially restore the sense of touch and decrease pain using AI-driven non-invasive neurostimulation.

Our multi-national, interdisciplinary team is looking for a "Quality Specialist" (80%-100%) that will drive the establishment of our Quality Management System and play an active role in our small but agile team.

Job description

As the Quality Specialist, you will play a pivotal role in ensuring the highest quality standards for our active medical devices, classified as class II. Your expertise will contribute in establishing and maintaining a robust Quality Management System (QMS) in compliance with ISO 13485 and 21 CFR Part 820 and applicable regulatory requirements. Your guide will contribute to foster a culture of quality and excellence where every team member contributes to upholding our commitment to product safety and effectiveness and regulatory compliance.

Responsibilities:

• Coordinate activities to develop and maintain our Quality Management System (QMS) for class II medical devices, complying to ISO 13485 and 21 CFR 820 requirements and applicable regulations/programs (e.g., MDR, FDA QMS Regulation, MDSAP)
• Develop, implement, and sustain comprehensive quality assurance procedures.
• Provide quality guidance to cross-functional teams, aiding and training them in developing and maintaining QMS procedures relevant to their respective responsibilities.
• Coordinate and actively participate in quality and regulatory inspections, adeptly reporting and contribute to addressing any quality/regulatory related issues that may arise.
• Coordinate the regular assessment and continuous improvement of the efficacy of our QMS through meticulous metric analysis and audits.
• Conduct internal audits and coordinate external audits of suppliers and contract manufacturers to verify compliance with quality and regulatory requirements.
• Support development efforts, particularly by reviewing engineering testing (such as software and electrical safety), to ensure adherence to compliance standards like IEC 62304 and IEC 60601-1.
• Mentor the team, inspiring them to achieve and uphold quality objectives consistently.

Your profile

• Bachelor's or master's degree in engineering, life sciences, quality or regulatory affairs, or a related field.
• A minimum of 3 years of hands-on experience in Quality Systems Management, encompassing the entire lifecycle of medical devices. Familiarity with ISO 13485, and FDA 21 CFR Part 820, is essential.
• Proven experience in internal and external audits and adeptness in supporting quality and regulatory inspections.
• Prior exposure to CE marking or FDA clearance/approvals for class II medical devices is highly desirable.
• A collaborative team player, enthusiastic about working for a dynamic start-up company, proficient in communication, peer leadership, and creative problem-solving.
• Exemplary attention to detail and the ability to effectively prioritize tasks in a dynamic and fast-paced environment.
• Advanced training in design quality, quality control or manufacturing quality is considered an asset.
• Able to communicate on all stakeholder levels and coordinate with top management team for reporting and execution of quality/regulatory activities
• Strong interest in interdisciplinary work, willingness to dive into new topics and understand medical requirements.
• Good interpersonal skills, teamwork, multi-cultural compatibility.
• Fluency in English, German is desirable

Your workplace

Your workplace

We offer

• Highly motivated and engaging team determined to improve patient's lives.
• Continuous improvement mindset
• Inclusive environment with great team spirit
• Further benefits according to ETH Zurich employee benefits program

We value diversity

Curious? So are we.

We look forward to receiving your online application with the following documents:

• CV (mandatory)
• Selfie video explaining your motivation (optional but highly reccomended) or motivation letter

Upload the video on a platform of your choice (Dropbox, YouTube, Vimeo, Google Drive, ...) and include the URL link in a document (e.g. accompanying/motivation letter)

• 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 MYNERVA can be found on our website. Questions regarding the position should be directed to Dr. Greta Preatoni, email greta.preatoni@wysszurich.ch (no applications).

For recruitment services the GTC of ETH Zurich apply.

About ETH Zürich

Curious? So are we.

We look forward to receiving your online application with the following documents:

• CV (mandatory)
• Selfie video explaining your motivation (optional but highly reccomended) or motivation letter

Upload the video on a platform of your choice (Dropbox, YouTube, Vimeo, Google Drive, ...) and include the URL link in a document (e.g. accompanying/motivation letter)

• 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 MYNERVA can be found on our website. Questions regarding the position should be directed to Dr. Greta Preatoni, email greta.preatoni@wysszurich.ch (no applications).

For recruitment services the GTC of ETH Zurich apply.