Certification Specialist Medical Devices (m/f/d)

CSA Group; Plattling; Hybrid; EUR 45.000 - 75.000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen sucht einen engagierten Zertifizierungsspezialisten für Medizinprodukte, der eine Schlüsselrolle bei der Gewährleistung der Sicherheit und Konformität von Produkten spielt. Diese spannende Position umfasst die eigenständige Verwaltung von Zertifizierungsprojekten, die Bewertung von Produkten und die enge Zusammenarbeit mit Labortechnikern. In einem dynamischen, interkulturellen Umfeld haben Sie die Möglichkeit, an innovativen Projekten zu arbeiten und Ihre Ideen einzubringen. Wenn Sie eine Leidenschaft für Technik und Qualitätssicherung haben, ist dies die perfekte Gelegenheit für Sie, einen bedeutenden Unterschied in der Branche zu machen.

Leistungen

Flache Hierarchien

Homeoffice-Möglichkeiten

Attraktive Aufgaben und Projekte

Fitness- und Gesundheitsprogramm

Fahrradleasing

Betriebliche Altersvorsorge

Fortbildungsmöglichkeiten

Unbefristete Festanstellung

Qualifikationen

• Fundiertes Wissen über internationale Standards und Prüfverfahren.
• Erfahrung mit CSA, UL oder ähnlichen Zertifizierungsstandards ist von Vorteil.

Aufgaben

• Eigenverantwortliches Management von Zertifizierungsprojekten.
• Bewertung von Produkten gemäß nationalen und internationalen Standards.

Kenntnisse

Zertifizierung und Compliance

Projektmanagement

Interpersonelle Fähigkeiten

Detailorientierung

Kommunikationsfähigkeiten

Ausbildung

Bachelor- oder Masterabschluss in Biomedizinischer Technik

Ähnlicher Abschluss in Elektrotechnik

Tools

Microsoft Office

Laborwerkzeuge

Jobbeschreibung

Certification Specialist Medical Devices (m/f/d)

Apply

locations: Plattling
time type: Full time
posted on: Posted 11 Days Ago
job requisition id: R002797

Employment Status:

Regular

Time Type:

Full time

BUILDING A WORLD CLASS TEAM STARTS WITH YOU

At the heart of CSA Group is a vision: making the world a better, safer, more sustainable place. It's been part of our mission for nearly one hundred years: from the first engineering standard for railway bridges developed in 1919, to more than 3,500 standards, codes & related products today.

Headquartered in Canada, with a global footprint of more than 30 labs and offices across Europe, Asia and North America, CSA Group tests, inspects and certifies a wide range of products - from everyday household items to leading edge technology - to meet exacting requirements for safety, performance and environmental impact.

Our employees take pride in making a difference in people's lives through the work that we do. We're looking for people like you to help make it happen.

Job Summary:

We are seeking a Certification Specialist (Medical Devices) who will play a critical role in ensuring that medical products meet all necessary safety and regulatory standards. This role focuses on evaluating products, interpreting standards, and certifying their compliance to ensure they are safe and ready for the public marketplace. The position requires a strong understanding of standards, processes, and regulatory requirements, combined with project management and client communication skills.

These are your tasks:

• Independently manage certification projects, ensuring compliance with all applicable safety requirements and adhering to time and budget constraints.
• Assess products against national and international standards, providing detailed evaluations and precedent-based decisions.
• Review and approve test data, technical reports, and certification documents to authorize the application of certification marks.
• Collaborate with lab technicians to define testing requirements, prioritize workflows, and determine the necessary resources.
• Provide clear and professional communication with clients regarding project timelines, compliance issues, and certification outcomes.
• Conduct construction evaluations to ensure product designs meet regulatory standards and document compliance rationale.
• Mentor team members, offering expertise to improve their knowledge and support their development in certification practices.
• Prepare, review, and approve test reports and results with a focus on accuracy and detail.
• Perform risk and hazard analyses related to safety aspects, including compliance review for software and usability documentation.
• Maintain a high level of productivity and adherence to company expectations for quality and efficiency.

What we expect:

• A Bachelor’s or Master’s degree in a relevant field such as Biomedical Engineering, Electrical Engineering, or equivalent experience in certification and compliance.
• In-depth knowledge of international standards and testing procedures, including familiarity with IEC 60601 series.
• Experience with CSA, UL, or similar certification standards is a strong advantage.
• Exceptional organizational skills, with the ability to manage multiple certification projects simultaneously.
• Strong interpersonal and communication skills to collaborate with clients, colleagues, and cross-functional teams.
• Proficiency in English (written and spoken); good knowledge of German or additional languages are a plus.
• A detail-oriented mindset with the ability to see the "big picture" and ensure timely, accurate delivery of projects.
• Familiarity with engineering drawings, laboratory tools, and Microsoft Office applications.
• A proactive and self-motivated approach to problem-solving and project management.

What we offer:

• Flat hierarchies in a professional and intercultural corporate environment
• Opportunity to work from home and flexible working hours
• Attractive tasks, exciting projects and the opportunity to contribute your own ideas
• Fitness and health program for a relaxed balance to the daily work routine
• Lease a Bike
• Company pension plan and opportunities for further training
• Permanent direct employment and a future-proof job

CSA Group is an Equal Opportunity Employer and is committed to diversity, equity, and inclusion. We prohibit discrimination and harassment of any kind based on any grounds stipulated by applicable laws. We are an organization where opportunities are based on skills and abilities, and differences are respected and valued. Please contact us at [e-mail] if you require accommodation in the interview process.