Quality Assurance Engineer

At Getinge we have the passion to perform

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers – and to save more lives.

The Getinge Applikon production site is located in Delft (NL), where advanced bioreactor systems from laboratory to pilot and production scale are developed and produced. We support the pharmaceutical industry (vaccines, regenerative drugs, antibodies, body tissues, biopharmaceuticals and biosimilars) as well as industrial microbiology (enzymes, food & beverage, nutraceuticals, biofuels, biochemicals and bio-plastics) in their upstream process. In doing so, we offer reliable solutions that make it possible to save lives.

Are you looking for an inspiring career? You just found it.

Do you have experience in Quality Assurance, enjoy optimizing business processes, and want to contribute to the development of our products within cross-functional teams? If so, continue reading to determine if this position aligns with your goals!

As a Quality Assurance Engineer, you will be responsible for documenting and administering ISO 9001:2015 and ISO 14001 certification of our quality system. You will actively participate in or coordinate Corrective and Preventive Action (CAPA) and Root Cause Analysis (RCA) processes to facilitate business optimization and ensure compliance with quality standards. When necessary, you have the authority to halt processes due to unacceptable quality risks. Additionally, you will engage in product teams, Continuous Improvement Methodology (CIM) teams, and other relevant forums to address quality-related issues and contribute to enhancing final products, as well as refining development, assembly, and testing processes.

Key responsibilities include, but are not limited to:

• Guiding employees in creating and implementing quality system documents.
• Coordinating and conducting internal, customer, and supplier audits in collaboration with departmental management, including follow-up on findings and reporting to relevant stakeholders.
• Assisting in drafting the quality policy and preparing Management Review reports.
• Providing education and training on quality tools and techniques to employees.
• Acting as a liaison between different teams within Getinge to facilitate cross-functional collaboration for product and process improvements, and ensuring compliance with applicable laws and regulations.
• Supporting all departments in CAPA requests and activities, including scheduling, monitoring, reviewing, and reporting on CAPA Key Performance Indicators (KPIs).
• Administering the Quality Management System and Environmental Management System.
• If you're passionate about ensuring quality standards, driving process improvements, and contributing to the success of our products, we encourage you to apply for this rewarding opportunity.

Knowledge, skills and experience
We are seeking a candidate who holds a degree in Business Administration, Mechanical Engineering, Environmental Science, or Laboratory Technology at the Dutch HBO level, coupled with a minimum of 5 years of experience in a similar role. As a candidate, you possess strong verbal and written proficiency in both Dutch and English, and exhibit excellent interpersonal skills. Your analytical prowess allows you to grasp both the big picture and the finer details of complex issues. Moreover, you are well-versed in ISO 9001:2015, ISO 14001:2015, 'Good Documentation Practices', and 'Good Manufacturing Practice'. With a proactive, adaptable, and collaborative mindset, you are eager to contribute to team efforts aimed at enhancing processes and refining products.

About us

Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. We are committed to diversity, equity and inclusion and to sustainability with a goal to be CO2 neutral by 2025. We believe in giving our employees the flexibility they need and make every effort to foster a learning culture that supports their personal development and creativity. Our passionate people hold our brand promise ‘Passion for Life’ close to heart. 

If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world’s most respected and trusted medtech company.