Quality Manager

Direct message the job poster from JFR Medical Instruments GmbH

JFR Medical Instruments GmbH, a medical device manufacturer, has been dedicated to the development and production of devices for non-invasive home ventilation and respiratory therapy since 2014. Our \“Made in Germany\“ products are designed to provide effective and user-friendly solutions for both patients and healthcare professionals.

Our expertise lies in creating reliable, high-quality products and services for the respiratory therapy market. Furthermore, we specialize in the design and manufacture of innovative products for sleep therapy. Continuous product development is central to our mission. We ensure that our devices meet stringent standards, are user-friendly, and deliver optimal performance.

JFR Medical Instruments GmbH, located in Heikendorf, Germany, is certified according to EN ISO 13485 and MDR.

At JFR Medical, we are committed to helping individuals and their families improve their lives with our products.

Responsibilities:

1. Serve as the primary point of contact for quality-related matters.
2. Maintain and continuously improve the quality management system in accordance with ISO 13485 and MDR requirements.
3. Implement internal quality guidelines.
4. Establish standards, processes, and structures within the company.
5. Ensure compliance with statutory standards and guidelines.
6. Plan, conduct, and participate in internal and external inspections and audits.
7. Conduct employee training on quality and safety.
8. Monitor processes and perform production-related controls, reporting to the management.
9. Perform post-market surveillance for all developed products, including data collection, analysis, and reporting.
10. Monitor risk management procedures, maintain issue logs, and report issues to management.

Qualifications:

1. Successfully completed engineering degree, preferably in medical technology.
2. Excellent knowledge of ISO 13485 and MDR requirements, preferably the Quality System Regulation 21 CFR 820.
3. Several years of experience in quality management, preferably in medical technology and production.
4. Strong communication skills, as well as an analytical and goal-oriented approach.
5. High social competence, initiative, and motivation.
6. Excellent English and German language skills, both written and spoken.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance

Industries

Medical Equipment Manufacturing

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