QA Engineer – Applikon Biotechnology B.V. – Delft

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

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

Become an Quality Assurance Engineer at Getinge Applikon

Do you have experience within Quality Assurance, enjoy optimizing business processes, and want to participate in cross-functional teams to help develop our products? Then read on and find out if this position is right for you!

As a Quality Assurance Engineer, you are responsible for the documentation and administration of ISO 9001:2015 and ISO 14001 certification of the quality system. You participate / coordinate in CAPA / RCA processes to enable business optimization and to ensure the quality system remains up-to-date with the standards. Where needed you can stop the process due to an unacceptable quality risk.

In addition, you take part in product teams, CIM teams on any quality topic, assist in improving the final product, but also the development and the assembly and testing processes.

Core duties and responsibilities may include, but are not limited to:

Guiding employees in the creation and implementation of quality system documents.

Coordinating and performing internal, customer and supplier audits in collaboration with department management also including follow up of any finding and reporting to the Notified body / customers / suppliers.

Assisting in drafting of the quality policy.

Preparing Management Review reports.

Educating and training employees on the use of quality tools and techniques.

Act as a liaison between the separate Getinge teams to enable the cross-functional product teams to improve products and processes, and to implement the applicable laws and legislation into the product portfolio.

Support all departments on CAPA request and activities. Schedule, monitor, review, and report on behalf of the subsequent CAPA KPI’s.

Administration of the Quality Management system and Environment Management System.

Knowledge, skills and experience

We are looking for a candidate who has completed his/her education in Business Administration, WTB/E, Environment or Laboratory Technology at the Dutch HBO level, with at least 5 years of working experience in a similar position.

As a candidate, you have a good verbal and written command of the Dutch and English language and are considered to be socially adept.

You are analytical and can keep an overall view of the whole issue as well as the details of an issue.

Finally, you are familiar with ISO 9001:2015, ISO 1400:2015. ‘Good Documentation Practices’ and ‘Good Manufacturing Practice’. You have a focused, flexible, proactive, and collaborative mindset and are willing to assist in teams to develop and improve both processes and products.

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

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