Quality Engineer

+++ Company + Devices +++

Chance to join a small team, onsite manufacturing. ...

We are looking for a Quality Engineer willing to grow rapidly to management position. 2 years exp.

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The Quality Engineer plays a pivotal role in maintaining and elevating the quality standards of our development and manufacturing processes. This role involves a diverse set of responsibilities including establishing and maintaining quality documentation, providing support for quality system procedures, managing CAPAs, KPI’s, the e-QMS, the Quality Plan and more.

The Quality Engineer collaborates closely with both the Manufacturing Manager (MAM) and the Quality & Regulatory Manager (QAM), ensuring the adherence of our processes to regulatory requirements.

Quality Documentation & Systems
Keep our quality documentation sharp. Build and maintain procedures, instructions and forms, ensure records are accurate, and guide teammates through QMS processes.

Performance Insights
Track and trend Process KPIs to surface meaningful insights into our QMS and manufacturing operations.

Non-Conformities & CAPAs
Drive the resolution of non-conformities. Manage and monitor corrective and preventive actions stemming from audits and manufacturing findings, and see them through to effectiveness.

Supplier Management
Be part of the full supplier lifecycle: evaluate, audit, qualify, and approve suppliers to keep quality inputs flowing into our manufacturing process.

Manufacturing & Purchasing Support
Work with the Manufacturing Manager in Process Validation activities. Help manage Purchase Orders and stay in close contact with suppliers.

Sterility Assurance & Batch Release
Get hands-on with our devices sterilization process, review production records, and perform product release.

e-QMS Ownership
Continue shaping how our electronic QMS runs:

• Build and maintain e-QMS procedures and workflows
• Train and support the team on system features
• Configure and customize the platform to fit our needs
• Track system performance and drive continuous improvements
• Oversee validation, change management, and user acceptance testing

Regulatory Affairs
Support the team in preparing regulatory submissions for both Europe and the USA.

Experience with electronic QMS

• Growth: Opportunity to join an ambitious neurotechnology startup with exposure to multiple areas of company operations.
• Culture: A collaborative and dynamic team environment with direct interaction with founders and leadership.
• Flexibility: Hybrid work model with the possibility of 1 day of remote work per week.
• Compensation: Salary range of 75'000-85'000 CHF per year based on experience and training.
• Ownership: Equity participation through the employee option plan may be available.