20 beste Stellen als medical device quality in münchen – aktuell auf Personalsuche

Validation & Verification (V&V) Engineer – Medical Imaging
Quest Global —München
- 55.000 € – 85.000 € pro Jahr
- Vollzeit
- Informatik
- Master
- Bachelor
Direkt bewerben
2 Tage
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Specialist (m/f/d) Regulatory Affairs & Quality
Abbott Laboratories —München
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Quest Global —München
- 55.000 € – 90.000 € pro Jahr
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Sobi —München
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ocumeda AG —München
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LUMA Vision —München
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Syneos - Clinical and Corporate - Prod —München
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IQVIA —München
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Edwards Lifesciences —Garching bei München
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PULSION Medical Systems SE —München
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North American Science Associates Ltd. —München
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Medpace, Inc. —München
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Beckman Coulter Diagnostics —München
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Freelance Medical Writer - Ophthalmology & AI-MDSW (w/m/d)
deepeye Medical GmbH —München
- 80 € – 120 € pro Stunde
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Validation & Verification (V&V) Engineer – Medical Imaging

Quest Global -
München

Direkt bewerben

Details zur Stelle

Vollzeit
55.000 € – 85.000 € pro Jahr
vor 2 Tagen

Qualifikationen

Informatik
Master
Bachelor
Medizinische Bildverarbeitung
Medizinische Dokumentation

Vollständige Stellenbeschreibung

Job Requirements

At Quest Global, it’s not just what we do but how and why we do it that makes us different. With over 25 years as an engineering services provider, we believe in the power of doing things differently to make the impossible possible. Our people are driven by the desire to make the world a better place—to make a positive difference that contributes to a brighter future. We bring together technologies and industries, alongside the contributions of diverse individuals who are empowered by an intentional workplace culture, to solve problems better and faster.

Key Responsibilities

Plan, design, and execute manual verification and validation activities for medical imaging software applications.
Develop, review, and maintain verification and validation protocols, test plans, test cases, and test reports.
Validate software features against functional, system, and user requirements.
Perform system, functional, integration, regression, and usability testing.
Identify, document, and track software defects through resolution using defect management tools.
Ensure all V&V documentation complies with applicable medical device software development and quality management standards.
Collaborate with Software Development, Product Management, Clinical Specialists, and Regulatory teams throughout the software development lifecycle.
Review software requirements and design documents to ensure completeness and testability.
Participate in risk-based testing and traceability activities to ensure comprehensive test coverage.
Support release readiness by providing verification evidence and quality documentation.
Gain exposure to DevOps concepts and support validation activities within CI/CD environments where applicable.

We are known for our extraordinary people who make the impossible possible every day. Questians are driven by hunger, humility, and aspiration. We believe that our company culture is the key to our ability to make a true difference in every industry we reach. Our teams regularly invest time and dedicated effort into internal culture work, ensuring that all voices are heard.

We wholeheartedly believe in the diversity of thought that comes with fostering a culture rooted in respect, where everyone belongs, is valued, and feels inspired to share their ideas. We know embracing our unique differences makes us better, and that solving the worlds hardest engineering problems requires diverse ideas, perspectives, and backgrounds. We shine the brightest when we tap into the many dimensions that thrive across over 21,000 difference-makers in our workplace.

Work Experience

Qualifications

Bachelor's or Master's degree in Computer Science, Biomedical Engineering, Electronics, or a related engineering discipline.
6-8 years of experience in software Verification & Validation (Manual Testing).
Experience developing verification protocols, validation protocols, test plans, test cases, and test reports.
Strong understanding of software testing methodologies and the Software Development Life Cycle (SDLC).
Experience with defect tracking and test management tools such as Jira, DevOps, or equivalent.
Excellent analytical, documentation, and problem-solving skills.
Basic understanding of DevOps concepts and software deployment workflows.
Strong communication and cross-functional collaboration skills.
Knowledge of and experience working within medical device quality and regulatory frameworks, including IEC 62304 (Medical Device Software Lifecycle Processes), ISO 13485 (Quality Management Systems), ISO 14971 (Risk Management), FDA 21 CFR Part 820/QMSR, and EU Medical Device Regulation (MDR).
Experience applying regulatory requirements and industry best practices throughout the software verification and validation lifecycle for medical imaging products.
Familiarity with compliance documentation, traceability, risk management, and software validation activities required for regulated medical device environments.
Understanding of global medical device standards and regulatory expectations governing the development, testing, and release of healthcare software solutions.
German language proficiency

Preferred Qualifications

Experience in the Medical Imaging or Healthcare Software domain.
Knowledge of DICOM, PACS, HL7, or FHIR standards.
Experience preparing validation documentation in accordance with organizational and medical device quality processes.
Exposure to regulated software development environments and design verification activities.

Technical Skills

Manual Verification & Validation Testing
Test Protocol, Test Plan, Test Case & Test Report Authoring
Functional, System, Integration & Regression Testing
Defect Tracking and Test Management
Requirements Traceability
Risk-Based Testing
Medical Device Documentation
Jira/Rally
Basic AWS Knowledge
Basic DevOps Knowledge
Medical Imaging Domain Knowledge (Preferred)

Benefits

based on seniority & experience, our budget for the role is between 55k - 85k Euro gross/year

Direkt bewerben

Erweiterte Suche

medical device quality Jobs in münchen

Validation & Verification (V&V) Engineer – Medical Imaging

Data Scientist with focus Bioinformatics / Diagnostics (f/m/d - part/full-time)

Specialist (m/f/d) Regulatory Affairs & Quality

Test Automation Engineer – Medical Imaging

Medical Device und Pharmacovigilance Manager

Regulatory, Quality & Compliance Lead (m/w/d)

Clinical Development Scientist

Medical Deep Learning Computer Vision Engineer (m/w/d)

Registered Nurse - Munich, Germany - Independent Contractor

Clinical Interview Rater (CIR) – German Speaking

Clinical Research Associate / Senior CRA

(Associate) Engineer (m/f/d) Development Consumables

Product Reviewer (IVD Clinical Review / E-ICR) (w/m/d)

Clinical Research Associate - French Speaking - Any EMEA location

Regulatory Submissions (Study Start-up) Manager

Manufacturing Quality Engineer (f/m/d)

Freelance Medical Writer - Ophthalmology & AI-MDSW (w/m/d)

Product Reviewer - Technische Dokumentation IVD (f/m/d)

Senior QA Engineer (m/f/d)

Continuous Improvement Lead (Innovation DBS Leader) (f/m/d)

Ich möchte aktuelle Job-E-Mails für Stellen als medical device quality in münchen erhalten

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