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Quality Assurance Specialist

vor 2 Monaten


Northeim, Niedersachsen, Deutschland Cytiva Vollzeit

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.