Quality Engineer

Contenuto del lavoro

Within Terumo Europe (TE), your scope is Terumo Pharmaceutical Solutions (PS), offering pharmaceutical companies comprehensive product design and development services as well as a portfolio of injection, infusion and primary packaging solutions. Next to the EMEA Headquarters, in Haasrode (Leuven) we also have the manufacturing plant for PS.

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

• Provide quality related support to production in case of deviations or projects.

• Active stimulation of continuous improvement through set-up and active participation of improvement projects related to GPs requirements.
• Interaction with PS 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 PS customers. Taking the lead in external audits.
• Handling of product complaints of PS 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.
• Perform supplier audits to ensure that selected suppliers can guarantee the required quality.
• Provide pro-actively information and training about the current quality requirements and GMP-rules to PS-related departments. Ensure yearly GMP-training for all TE employees.

• 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

• 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.

Peter Coolen

Talent Acquisition Partner

• 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.

Peter Coolen

Talent Acquisition Partner