Quality Engineer - Negenborn, Deutschland - Cytiva

Beschreibung

Join us at Cytiva and be part of changing lives.

Cytiva is a global provider of technologies and services that drive and accelerate the development and manufacturing of therapeutics. Our customers make a significant contribution to increasing life expectancy, from biological research to the development of innovative vaccines, novel drugs, as well as cell and gene therapies.

At Cytiva, you have the opportunity to continuously develop yourself and the company - tackling important challenges with people dedicated to each other, to our customers, and their patients. With employees in 40 countries, Cytiva is a place where every day offers the chance to learn and grow, advancing your career and expanding your skills in the long term.

As part of Danaher's biotechnology segment, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.

To support our Quality Assurance Team in Dassel, we are looking for a Quality Engineer (m/f/d) full-time.

What you will do

• Ensure compliance with ISO9001 and ISO13485 standards by leveraging your expertise, working closely with the quality team to ensure adherence and drive continuous improvement of quality management systems.
• Actively support NPD programs as a member of an interdisciplinary team, ensuring they meet the strict requirements of the Cytiva design and development process. Contribute to robust quality plans for new products, processes, and technologies.
• Work with project and process engineering teams to ensure proper validation of work transfers or new processes. Review and approve validation plans, protocols, and reports to ensure regulatory compliance and product quality.
• Prepare impact assessments and approve change action plans and effectiveness tests as part of the change control process. Conduct risk assessments to identify and address potential impacts on product quality and regulatory compliance.
• Provide input and leadership for continuous improvement activities covering quality management systems, product, and process activities. Lead interdisciplinary teams in identifying improvement opportunities and implementing sustainable solutions for continuous performance enhancement.

Who you are

• Bachelor's degree in a technical, scientific, or related field of study.
• Minimum of 5 years of experience in the medical device or life sciences industry.
• Demonstrated knowledge of ISO9001 and ISO13485 quality systems.
• Strong technical skills, including the ability to read and understand technical documents and execute procedures, along with a demonstrated understanding of system documentation.
• Strong analytical skills, problem-solving abilities, and experience in root cause analysis.

What we offer

• Collective compensation with a 35-hour workweek, along with vacation and Christmas bonuses.
• Various benefits such as fitness subsidies, accident insurance, company pension, and employer savings benefits.
• Healthcare provisions, such as preventive check-ups.
• Opportunities for professional development International.
• Corporate environment in a rapidly growing industry.

Cytiva is a leading global biotechnology company with over 7000 employees in 40 countries.

Cytiva is part of the Danaher Corporation, a global scientific and technological innovative company dedicated to helping customers solve complex challenges and improve quality of life worldwide.