Product Quality Engineer – Medical Technology (m/f)

About the job

Are you passionate about quality in the service of health?

Skills to join Auctae in Switzerland as a product quality engineer – medical technology

Excellent communicator – French and English – results-oriented, you are methodical, autonomous, persevering and have an excellent team spirit and a very good sense of organization.

Generalist engineer, biomedical, mechanical or equivalent, you have initial experience in quality within the medical device, pharmaceutical or biotechnology industry (risk analysis, supplier quality management, production quality management, process validation). You have good knowledge of European (MDR) and American (FDA) regulatory requirements and experience in an ISO 13485 or ISO 9001 certified environment.

Join Auctae in Switzerland as a product quality engineer – medical technology

By joining Auctae as a product quality engineer – medical technology, you are the guarantor of regulatory compliance and the maintenance of the quality system. You master ISO 13485 and ISO 9001 standards, as well as common quality tools such as FMEA, CAPA, 8D, MSA, APQP, etc.

Your main tasks:

• Develop and implement internal quality policies and procedures, and ensure compliance with applicable medical device standards (ISO 13485, MDR 2017/745, FDA 21 CFR Part 820, etc.);
• Supervise and lead product and process validation and qualification activities – IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification);
• Conduct non-conformity investigations – NC and lead corrective and preventive actions – CAPA – corrective action and preventive action;
• Actively participate in the continuous improvement process of the quality system;
• Prepare quality and regulatory documentation related to project milestones (DHF, DMR, DHR);
• Act as the main interface for customers, suppliers and auditors for all quality and device safety related matters;
• Collaborate with the supplier quality department to ensure compliance of critical components;
• Lead problem resolution with quality tools (8D, Ishikawa, 5 Why);
• Perform and document first article inspections – FAI first article action – when required;
• Manage customer returns, complaints and field investigations.

Are you Swiss or a national of one of the European Union member states?

Position open to all persons matching the profile. Permanent contract (CDI).

We are Auctae, a Swiss company based in the Lake Geneva region, driven by augmented innovation: engineering, project management and the industry of the future.