Medical Device Quality Assurance Specialist
vor 2 Monaten
Job Description
Role
- Contribute to the development of innovative medical devices, focusing on electronic, software, and mechanical aspects.
- Ensure compliance with quality requirements for drug delivery systems and medical devices in development projects, guaranteeing adherence to regulatory standards.
- Oversee the conformity of products and product documentation throughout the product life cycle, with a focus on development and industrialization, including Design Control.
- Collaborate in risk analyses to identify and mitigate potential issues.
- Create and approve documents for design verification and design validation, ensuring accuracy and compliance.
- Develop and release test plans, test setups, and design of experiments to validate product performance.
- Review and approve changes to product design and manufacturing processes, ensuring quality and regulatory compliance.
- Act as the primary contact for customers and suppliers regarding product quality, including non-conformities, corrective actions, and supplier control.
- Collaborate in equipment qualification, process validation, and evaluation of external production partners to ensure quality and compliance.
- Serve as the primary contact for quality-related questions during customer or authority audits.
Qualifications
Profile
- Hold a completed technical or scientific education or equivalent.
- Possess several years of experience in the field of medical technology products, pharmaceuticals, and/or in-vitro diagnostics.
- Have practical experience in risk management methods for medical devices.
- Apply quality and problem-solving techniques effectively.
- Understand and implement regulatory requirements for medical devices, including MDR, EN ISO 14971, 21 CFR 820, and EN 13485.
- Work in a structured and result-oriented manner.
- Be willing to proactively participate and make things happen, with the ability to prioritize and make decisions.
- Exhibit a solution-oriented and communicative personality.
- Confidently communicate across all hierarchical levels, internally and with customers.
- Be willing to travel approximately 10% of the time.
- Possess very good oral and written language skills in German (B2) and English (C1).
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