Quality Systems Expert
il y a 3 semaines
_At Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are driven by respect, ownership and continuous improvement. It is at the heart of everything we do. This is how we make a difference in the lives of patients, customers and associates._
**Department Info**:
Terumo EMEA Quality operating from Haasrode, Belgium, provides supporting services in quality systems, quality assurance and quality control to Terumo internal and external customers on an EMEA basis.
**Job Summary**:
As part of this department, the QS Validation Expert ensures the quality oversight of the process validation activities. Main responsibility is to ensure EO sterilization validation and process validation activities comply with the applicable European and FDA regulations, guidelines and Terumo Global Quality Policies.
**Responsibilities**:
**Most of the time, you’ll be involved in maintaining the Process validation and EO Sterilization validation process in Terumo Europe, more concrete**:
- You’ll maintain the QMS procedures on process validation of EO sterilization and manufacturing processes, including risk management process (process FMEA) to be compliant with applicable European and FDA regulations, guidelines and Terumo Global Quality Policies.
- You’ll supervise the EO sterilization validation engineer and train the process validation engineers.
- You’re responsible for maintaining and doing the follow-up of the VMP’s and periodic reviews to ensure that processes are timely re-validated.
- You’ll review and approve EO sterilization validation files for compliance with EN ISO 11135
- You’ll coach QA engineers in the review process of process validation files and monitor this review process.
- Follow-up EO Sterilisation validation subcontractor
- Responsible for non-conformity handling related to process and sterilisation validation issues (including audit non conformities): investigate CAPA need, guide investigation to the root cause of the non-conformity and review corrective actions proposed. Ensure proper documentation and follow-up implementation of corrective actions, effectiveness evaluations for CAPA and closure of the non-conformity.
**A smaller part of your time, you’ll execute and support quality systems audits**
- You’ll participate in the internal audits of Terumo Europe
**Profile Description**:
- University or technical degree in engineering, scientific, medical or pharmaceutical oriented education, or equivalent by experience
- Experience in the technical domain of EO sterilisation validation and process validation.
- Profound knowledge of EN ISO 11135, EN ISO 13485, 21 CFR Part 820, GHTF/SG3/N99-10
- Minimum 5 years professional experience in medical and/or pharmaceutical environment
- Good working knowledge of English (written and spoken). Knowledge of French is an asset.
- Team player with strong communication skills to collaborate with different partners across our organization
- Being able to work accurately according to guidelines
- Open to work full time
**Offer**:
Working for Terumo means contributing to society through healthcare.
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.
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 this role, you’re allowed to work very flexible switching between home or office based. To ensure team connection, presence in the office is asked on Monday (morning) for weekly team meeting.
During your recruitment process, you’ll be able to have conversations with Bert Pipeleers as the hiring manager and other passionate Terumo associates.
Interested to contribute to the growth of Terumo? Interested to find out more? Have a look at Terumo Europe's Corporate Video or visit our website
**Contact Person**:
Bethsabee Bellinck.
- Terumo Europe is a core player in the EMEA healthcare market. We are a strong actor of the Terumo Corporation (Japan), producing, distributing, marketing and selling a vast range of medical devices. Terumo Europe EMEA headquarters and production facilities are located in Leuven (Belgium) with sales and marketing offices across the EMEA region._
-
Quality Control Operator
Il y a 7 mois
Leuven, Belgique 3D Systems Leuven Temps plein**About 3D Systems Belgium** 3D Systems Belgium, formerly LayerWise, is a dynamic and leading enterprise, specialized in 3D Printing of metal components. 3D Systems Belgium is part of the international company 3D Systems. 3D Systems is a renowned developer of 3D-printers and a contract manufacturer of 3D printed parts. The synergy of both activities makes...
-
Quality Systems Coordinator
Il y a 4 mois
Leuven, Belgique Integrated DNA Technologies (IDT) Temps pleinIDT is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health. This position is part of the QMS department located in Leuven, Belgium. At IDT, we are one global team. We celebrate our differences, engage in healthy debate, and are inclusive. Together,...
-
Quality Systems Specialist
Il y a 7 mois
Leuven, Belgique Terumo Europe Temps pleinAt Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...
-
Quality Systems Specialist
il y a 3 semaines
Leuven, Belgique Terumo Europe Temps pleinAt Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are...
-
Quality Control Inspector
il y a 3 semaines
Leuven, Belgique 3D Systems Leuven Temps plein**OVER 3DSYSTEMS BELGIUM** 3D Systems Belgium, voorheen LayerWise, is een dynamische en sterk groeiende onderneming, gespecialiseerd in 3D printen van metalen componenten. 3D Systems is een gerenommeerde ontwikkelaar van 3D-printers en een contractfabrikant van 3D-geprinte onderdelen. De synergie van beide activiteiten maakt ons een sterke innovatiepartner...
-
Manager of Quality Systems
il y a 7 jours
Leuven, Belgique Integrated DNA Technologies (IDT) Temps pleinIDT is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives. We are currently looking for a Manager of Quality Systems (EMEA) for Leuven, Belgium. 70 % remote work possible. Essential...
-
Quality Assurance and Regulatory Affairs
il y a 3 semaines
Leuven, Belgique Comate Temps pleinComate is looking for a motivated **Quality Assurance and Regulatory Affairs (QA/RA) engineer **to support its growth and expansion in the **Life Sciences** sector. The aim of our passionate team is to cooperate with our clients in order to develop a unique product that is more innovative and more advanced than anything that is currently available on the...
-
Quality Administrator
il y a 2 semaines
Leuven, Belgique Integrated DNA Technologies (IDT) Temps pleinIDT is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives. We are currently looking for a Quality Administrator for Leuven, Belgium. The Quality Administrator is responsible to maintain and...
-
3D Printing Operator
Il y a 7 mois
Leuven, Belgique 3D Systems Leuven Temps plein**About 3D Systems Belgium** 3D Systems Belgium, formerly LayerWise, is a dynamic and leading enterprise, specialized in 3D Printing of metal components. 3D Systems Belgium is part of the international company 3D Systems. 3D Systems is a renowned developer of 3D-printers and a contract manufacturer of 3D printed parts. The synergy of both activities makes...
-
Benchmarking Technician
Il y a 7 mois
Leuven, Belgique 3D Systems Leuven Temps pleinAbout 3D Systems Belgium 3D Systems Belgium, formerly LayerWise, is a dynamic and leading enterprise, specialized in 3D Printing of metal components. 3D Systems Belgium is part of the international company 3D Systems. 3D Systems is a renowned developer of 3D-printers and a contract manufacturer of 3D printed parts. The synergy of both activities makes us a...
-
Optical System Design Expert
il y a 2 semaines
Leuven, Belgique IMEC Inc. Temps pleinOptical system design expertResearch & development - Leuven | Just now - Modeling, simulating, designing, and proof of concept development of new photonic and opto-electronic concepts for light emission, and sensing across visible and infrared- What you will do- - As Optical System Design Expert you will be responsible for: - Modeling, simulating, designing,...
-
A&c Systems
il y a 3 semaines
Leuven, Belgique CaptainWork Temps plein**Als Financeel Expert ben jij een duizendpoot binnen onze Finance afdeling. Jij duikt graag in analyses, volgt dossiers nauwkeurig op en schrikt er niet voor terug om moeilijke gesprekken met collega's en klanten aan te gaan.** **Functie** Een greep uit jouw takenpakket: - Debiteurenbeheer van A tot Z opvolgen. - Budget & closing van één van onze...
-
Ekinops Quality and Environmental Manager
il y a 2 semaines
Leuven, Belgique EKINOPS Temps plein**Location** Heverlee, Belgium **Contract type** Permanent, full time **Department** Operations **Purpose of the job** **Duties and responsibilities** - Site Quality and Environmental Manager in charge of maintaining the local ISO9001 and ISO14001 certifications and of the upcoming ISO27001 certification. This requires strong interaction with R&D (85% S/W,...
-
Metrologist
il y a 2 jours
Leuven, Belgique 3D Systems Leuven Temps plein**ABOUT 3D Systems Belgium** 3D Systems Belgium, formerly LayerWise, is a dynamic and leading enterprise, specialized in 3D Printing of metal components. 3D Systems Belgium is part of the international company 3D Systems. 3D Systems is a renowned developer of 3D-printers and a contract manufacturer of 3D printed parts. The synergy of both activities makes...
-
Clinical Laboratory Quality
il y a 2 semaines
Leuven, Belgique Medpace, Inc. Temps pleinJob Summary: Responsibilities: - Supporting Medpace’s Quality Event Management (QEM) program through triage, and facilitating QEM steps such as problem definition, investigation, root cause analysis, CAPA planning and CAPA effectiveness driving continuous improvement of Quality Management System. - Supporting further development systems, and tools to...
-
Project Buyer
il y a 3 semaines
Leuven, Belgique 3D Systems Leuven Temps plein**ABOUT 3D SYSTEMS LEUVEN**3D Systems Leuven, formerly LayerWise, is a dynamic and leading enterprise specialized in 3D Printing of metal components. 3D Systems Leuven is not only a technology developer but also a technology user. This makes us a strong innovation partner for clients in the industrial, medical and dental sector. With this technology we...
-
Laboratory Quality Assurance Auditor
il y a 5 jours
Leuven, Belgique Medpace, Inc. Temps pleinJob Summary: Medpace is a global, full-service Contract Research Organization (CRO) headquartered in Cincinnati, Ohio, and active in over 40 countries across the globe. We are looking to strengthen the Global Quality Assurance team with a Quality Assurance (QA) Auditor at Medpace Reference Laboratories. The QA Auditor will play an essential role in ensuring...
-
Commodity Buyer
il y a 5 jours
Leuven, Belgique 3D Systems Leuven Temps plein**About 3D Systems Belgium** 3D Systems Belgium, formerly LayerWise, is a dynamic and leading enterprise, specialized in 3D Printing of metal components. 3D Systems Belgium is part of the international company 3D Systems. 3D Systems is a renowned developer of 3D-printers and a contract manufacturer of 3D printed parts. The synergy of both activities makes...
-
Quality Supervisor
Il y a 7 mois
Leuven, Belgique AECOM Temps pleinBedrijfsomschrijving At AECOM, we’re delivering a better world. We believe infrastructure creates opportunity for everyone. Whether it’s improving your commute, keeping the lights on, providing access to clean water or transforming skylines, our work helps people and communities thrive. Our clients trust us to bring together the best people, ideas,...
-
Quality Specialist
Il y a 7 mois
Leuven, Belgique IMEC Inc. Temps pleinResearch & development - Leuven | Just now- Act as the point of contact for all quality related questions within the FAB engineering department.- What you will doYou will be working in IMEC’s FAB Engineering department. For this role, you will: - Act as single point of contact in the FAB Engineering department for quality and learning. - Able to act a as...
