Quality Engineer

Department Info

Within Terumo Europe (TE), your scope is Terumo Pharmaceutical Solutions (TPS), offering pharmaceutical companies comprehensive product design and development services as well as a portfolio of injection, infusion and primary packaging solutions and Terumo Medical Products (TMP), a leading manufacturer of injection and infusion therapy devices that help clinicians consistently perform at their very best.

Job Summary

Assist QA Manager MP/TPS in his function to guarantee that the TPS products meet the customer requirements (product and processes) and continuously improve the quality of the TPS products.

Job Responsibilities

• Interaction with TPS sales and marketing and production to secure that customer requirements are implemented in all stages of the production process. Completion of customer questionnaires and give technical replies to questions from TPS customers. Taking the lead in external audits.
• Handling of product complaints of TPS clients with focus on root cause solving in order to reach zero defect. Responsible for the keeping of records and complaint samples. Authorised for quality returns based on complaints. Active follow-up of the defined actions and countermeasures after audits and product complaints.
• Trend analysis on internal non-conformities and product complaints to ensure that the quality system is updated to detect timely main product quality problems. Proactively input to concerned departments.
• Authorised back-up for administrative release of finished products under supervision of the QA/QC manager.
• Perform supplier audits to ensure that selected suppliers can guarantee the required quality.
• Active stimulation of continuous improvement through set-up and active participation of improvement projects related to GPs requirements
• Provide pro-actively information and training about the current quality requirements and GMP-rules to TPS-related departments. Ensure yearly GMP-training for all TE employees.

Profile Description

• Higher scientific degree: (industrial) pharmacist, bio-engineer, industrial engineer, master in biomedical science with minimum first work experience
• Experience with pharmaceutical industry and GMP
• Knowledge of quality systems (ISO 13485, QSR)
• Having the right quality mindset: be alert, aware of risks and assertive.
• Languages: Dutch, English

Offer

• Working for Terumo means contributing to society through healthcare.
• We offer an opportunity to work in a top performing team. An organisation where everyone is treated with respect. We strive to create a diverse, equal and inclusive work environment. We invest in our associates by offering a broad array of development opportunities.

• Linked with our core value Care, Terumo allows a hybrid way of working, combining office with home-based work. For the Engineering team a regular presence in the office close to the manufacturing plant, combined with work at home is the guideline.
• Terumo offers an attractive salary and benefits package. Besides meal vouchers, interesting insurances, 100% public transport reimbursement, you also have the possibility to lease an (e-)bike.

During your recruitment process, you’ll be able to have conversations with Jeroen François as the hiring manager and other passionate Terumo associates.

Contact Person

Interested to contribute to the growth of Terumo? Interested to find out more?

Please contact Peter Coolen, Talent Acquisition Partner, and send your questions or resume to peter.coolen@terumo-europe.com