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Quality Assurance Specialist
vor 2 Monaten
About Cytiva
Cytiva is a global leader in the biotechnology industry, with over 7,000 employees in 40 countries. We are part of the Danaher Corporation, a global science and technology innovator that helps customers solve complex challenges and improve lives around the world.
Job Summary
We are seeking a Quality Engineer to join our team at our Dassel location. As a Quality Engineer, you will play a critical role in ensuring the quality of our products and processes, and contributing to the development of new technologies and innovations.
Key Responsibilities
Ensure compliance with ISO 9001 and ISO 13485 standards, working closely with the Quality Assurance team to maintain and improve our quality management systems.
Support the development of new products and processes, ensuring they meet Cytiva's design and development standards.
Develop and implement robust quality plans for new products, processes, and technologies.
Work with project and process engineering teams to ensure the validation of new processes and transfers is properly conducted.
Review and approve validation plans, protocols, and reports to ensure regulatory compliance and product quality.
Identify and address potential impacts on product quality and regulatory compliance through risk assessments.
Lead cross-functional teams to identify opportunities for continuous improvement, and implement sustainable solutions to drive performance excellence.
Requirements
Bachelor's degree in a technical, scientific, or related field.
At least 5 years of experience in the medical device or biotechnology industry.
Demonstrated knowledge of quality systems ISO 9001 and ISO 13485.
Technical expertise, including the ability to read and understand technical documents and perform procedures, as well as a proven understanding of system documentation.
Strong analytical skills, problem-solving skills, and experience in root cause analysis.
What We Offer
Competitive compensation with a 35-hour workweek, plus vacation and holiday pay.
Multiple benefits, including fitness cost reimbursement, accident insurance, company pension plan, and other benefits.
Healthcare services, including preventive care.
Opportunities for professional development and growth.
An international work environment in a rapidly growing industry.