Neurosoft Bioelectronics

Medical Equipment Manufacturing

1-10

Switzerland

**Applications will remain open until Friday June 30th 2023. Feedback will be provided during the following week.**

Neurosoft Bioelectronics is a neurotech startup focused on building **implantable electrodes to interface with the human brain**. We work in a state-of-the-art cleanroom environment and are looking for a **Quality Engineer** to join our dedicated team.

The **Quality Engineer** will play a pivotal role in maintaining and elevating the quality standards of our manufacturing processes. This role involves a diverse set of responsibilities including establishing and maintaining quality documentation, providing support for quality system procedures, reviewing production records, managing CAPAs, validation of processes and more. The Quality Engineer will collaborate closely with both the Manufacturing Manager (MAM) and the Quality & Regulatory Manager (QAM), ensuring the adherence of our processes to regulatory requirements.

## Tasks

*   Establish and maintain procedures relative to quality documentation, ensuring proper documentation and records are kept.
*   Provide support to collaborators on quality system procedures and forms, promoting quality assurance within the team.
*   Perform QA review of production records and facilitate the release of products.
*   Manage and monitor the implementation and effectiveness of CAPAs related to audit findings and non-conformities related to manufacturing activities.
*   Coordinate the trending of Processes Key Performance Indicators, providing crucial insight into our QMS and manufacturing processes.
*   Participate in the evaluation, audit, qualification, and approval of suppliers, ensuring high-quality inputs for our manufacturing process.
*   Support the Manufacturing Manager in Process Validation activities, ensuring robust and effective manufacturing processes.
*   Support the Quality & Regulatory Manager in preparing regulatory submissions in Europe and the USA.

## Requirements

**Knowledge, Skills and Abilities:**

*   In-depth knowledge of quality systems, quality assurance techniques, and regulatory standards (including ISO 13485 and FDA 21 CFR Part, 820).
*   Strong analytical skills with the ability to identify and implement process improvements.
*   Excellent problem-solving skills and the ability to conduct root cause analysis.
*   Strong communication skills and the ability to work effectively in a team-oriented environment.
*   Proficiency in the use of statistical analysis and quality improvement tools.
*   Attention to detail and precision in work, vital for maintaining product quality and integrity.
*   Proficiency in documenting all work reliably and accurately as per QMS standards.

**Education and experience:**

*   Bachelor’s or Master’s degree (or equivalent) in Quality, Mechanical, Biomedical Engineering, or a related field.
*   Minimum 2 years of experience in a Quality Engineering role, preferably in a medical device manufacturing environment.
*   Experience in implementing and managing CAPA systems.
*   Knowledge of and experience with regulatory submissions in Europe and the USA would be a plus.
*   Fluent in English (written and spoken). French and/or German are an asset.

Our team is passionate about creating innovative solutions that can make a positive impact on people's lives. Working in a small team, you will have the opportunity to collaborate with experts in different fields, share your ideas, and contribute to the development of cutting-edge healthcare solutions. We value creativity, collaboration, and continuous learning, and provide opportunities for professional growth and development. If you want to be part of something truly special, we would love to hear from you.

Employee

Professional / Experienced

Applications will remain open until Friday June 30th 2023. Feedback will be provided during the following week.
Neurosoft Bioelectronics is a neurotech startup focused on building implantable electrodes to interface with the human brain. We work in a state-of-the-art cleanroom environment and are looking for a Quality Engineer to join our dedicated team.
The Quality Engineer will play a pivotal role in maintaining and elevating the quality standards of our manufacturing processes. This role involves a diverse set of responsibilities including establishing and maintaining quality documentation, providing support for quality system procedures, reviewing production records, managing CAPAs, validation of processes and more. The Quality Engineer will collaborate closely with both the Manufacturing Manager (MAM) and the Quality &amp; Regulatory Manager (QAM), ensuring the adherence of our processes to regulatory requirements.
<h2 id="tasks">Tasks</h2>
<ul>
<li>Establish and maintain procedures relative to quality documentation, ensuring proper documentation and records are kept.</li>
<li>Provide support to collaborators on quality system procedures and forms, promoting quality assurance within the team.</li>
<li>Perform QA review of production records and facilitate the release of products.</li>
<li>Manage and monitor the implementation and effectiveness of CAPAs related to audit findings and non-conformities related to manufacturing activities.</li>
<li>Coordinate the trending of Processes Key Performance Indicators, providing crucial insight into our QMS and manufacturing processes.</li>
<li>Participate in the evaluation, audit, qualification, and approval of suppliers, ensuring high-quality inputs for our manufacturing process.</li>
<li>Support the Manufacturing Manager in Process Validation activities, ensuring robust and effective manufacturing processes.</li>
<li>Support the Quality &amp; Regulatory Manager in preparing regulatory submissions in Europe and the USA.</li>
</ul>
<h2 id="requirements">Requirements</h2>
Knowledge, Skills and Abilities:
<ul>
<li>In-depth knowledge of quality systems, quality assurance techniques, and regulatory standards (including ISO 13485 and FDA 21 CFR Part, 820).</li>
<li>Strong analytical skills with the ability to identify and implement process improvements.</li>
<li>Excellent problem-solving skills and the ability to conduct root cause analysis.</li>
<li>Strong communication skills and the ability to work effectively in a team-oriented environment.</li>
<li>Proficiency in the use of statistical analysis and quality improvement tools.</li>
<li>Attention to detail and precision in work, vital for maintaining product quality and integrity.</li>
<li>Proficiency in documenting all work reliably and accurately as per QMS standards.</li>
</ul>
Education and experience:
<ul>
<li>Bachelor’s or Master’s degree (or equivalent) in Quality, Mechanical, Biomedical Engineering, or a related field.</li>
<li>Minimum 2 years of experience in a Quality Engineering role, preferably in a medical device manufacturing environment.</li>
<li>Experience in implementing and managing CAPA systems.</li>
<li>Knowledge of and experience with regulatory submissions in Europe and the USA would be a plus.</li>
<li>Fluent in English (written and spoken). French and/or German are an asset.</li>
</ul>
Our team is passionate about creating innovative solutions that can make a positive impact on people&#39;s lives. Working in a small team, you will have the opportunity to collaborate with experts in different fields, share your ideas, and contribute to the development of cutting-edge healthcare solutions. We value creativity, collaboration, and continuous learning, and provide opportunities for professional growth and development. If you want to be part of something truly special, we would love to hear from you.

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