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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 a part of the Danaher Corporation, a global scientific and technological innovator that aims to improve the quality of life around the world.
Our Mission
We bring together science, technology, and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
Job Summary
We are seeking a Quality Engineer to join our team at our location in Dassel. As a Quality Engineer, you will be responsible for ensuring that our quality management systems meet the requirements of ISO 9001 and ISO 13485. You will work closely with our quality team to implement and maintain our quality management systems, and to identify and implement opportunities for improvement.
Key Responsibilities
Develop and implement quality plans for new products, processes, and technologies.
Work with project and process engineering teams to ensure that validation of transfers or new processes is conducted in accordance with regulatory requirements.
Review and approve validation plans, protocols, and reports to ensure regulatory compliance and product quality.
Identify and address potential risks to product quality and regulatory compliance through risk assessments.
Lead interdepartmental teams to identify opportunities for improvement and implement sustainable solutions to enhance product and process quality.
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.
Strong technical knowledge, including the ability to read and understand technical documents and perform procedures.
Strong analytical skills, problem-solving skills, and experience in root cause analysis.
What We Offer
Competitive compensation with a 35-hour workweek and holiday pay.
Multiple benefits, including fitness cost reimbursement, accident insurance, company pension plan, and other benefits.
Healthcare services, including preventive check-ups.
Opportunities for professional development and international career advancement.
A dynamic work environment in a rapidly growing industry.
