Quality Systems Specialist
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 main responsibilities of the Quality Systems Specialist are to support the Terumo Europe organisation to comply with the applicable quality system requirements for document control and training, by active participation in process improvements, by performing quality audits and leading the follow up of related non conformities.
Your team, led by Bert Pipeleers, works from our HQ based near Leuven Belgium. We offer a hybrid way of working with a mínimal presence of one day in the office. In this role you'll liaise with various stakeholders throughout our EMEA organisation.
**Responsibilities**:
**1. Execute and support quality systems audits**
- Participate in the internal audits of Terumo Europe
**2. Maintain the training QMS process in Terumo Europe**
- Maintain the training process and keep applicable procedures aligned with current standards and regulations.
- Support people managers of the different departments and HR in defining training requirements in the learning plans and assessments, based on knowledge of QMS requirements in the different areas.
- Review quiz assessments on QMS procedures.
- Represent QS in board to assess to which learning plans new procedures should be linked.
- Support HR in maintenance of the e-QMS learning module.
- Responsible for non-conformity handling related to training 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.
- Define and follow up of KPI’s to monitor the training process.
**3. Maintain the document management system in Terumo Europe**
- Maintain the document/record control process and keep applicable procedures aligned with current standards and regulations.
- Give training on document management system in e-QMS, technical writing of SOP’s and archiving of QMS records.
- Supervise group of master file coordinators
- Measure process performance with KPI’s
**Profile Description**:
- University or technical degree in engineering, scientific, medical or pharmaceutical oriented education, or equivalent by experience
- Minimum 3 years experience in quality department, including technical writing experience in medical and/or pharmaceutical field
- Profound knowledge of the QMS standards ISO 13485 and FDA 21CFR part 820 in order to be able to define learning plans in the different departments
- Experience as (internal) auditor as a preference
- Good working knowledge of English (written and spoken).
- Team player with strong communication skills to collaborate with a large variety of stakeholders
**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 Regulatory Affairs 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 and we offer 12 additional holidays on annual basis.
**Contact Person**:
Lukas Uytterhaegen - Talent Acquisition Business Partner EMEA
- 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._
-
Junior Quality Specialist
il y a 4 semaines
Leuven, Belgique QAELUM Temps pleinWe are currently looking for a junior Quality Specialist for our HQ in Belgium. Qaelum NV is a fast-growing medical software solutions provider caring about patient safety, efficiency and quality improvements in medical imaging environments. With our solutions, we are one of the market leaders in Europe and have installations all over the globe. We believe...
-
Quality Control Operator
il y a 1 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...
-
SAP Specialist
il y a 3 jours
Leuven, Belgique Engineering Systems NV Temps plein**About** PEC is an international technology supplier, committed to enable the production of green batteries for a Blue Planet. We are looking for a SAP support to join us in our mission to contribute to a greener future. The role is based in our Belgian Headquarters, located in Leuven. By joining us, you will contribute to building the first large scale...
-
QA Test Specialist
il y a 4 semaines
Leuven, Belgique Verotech Temps plein**About**: Are you interested in working with the most** advanced and cutting-edge technology**? We’re VeroTech, a Belgian engineering consultancy company specializing in R&D projects, currently looking for talented engineers. **Your mission**: As a **QA Test Specialist**, you will facilitate the operations between different systems and guard their...
-
EHS Digital System Specialist
il y a 3 jours
Leuven, Belgique IMEC Inc. Temps pleinEHS Digital System Specialist- Installation, Maintenance and Repair - Leuven | Just now- Is digitalisatie van processen je ding? Zin om dit te doen in een boeiende en internationale R&D omgeving? Dan is het EHS team van imec op zoek naar jou als Digital System Specialist!- Wat ga jij doen?Het Environment, Health and Safety (EHS) expertiseteam van imec...
-
Quality Associate
il y a 3 jours
Leuven, Belgique reMYND Temps pleinreMYND is a biopharmaceutical company focused on the development of treatments against protein-misfolding disorders, with two business units: **The Drug Discovery and Development (DDD) unit**, driving our own pipeline of disease-modifying treatments against diabetes, Alzheimer’s, Parkinson’s and orphan diseases **The CRO unit**, a world-wide leader of...
-
Qc Specialist
il y a 1 mois
Leuven, Belgique Talentus Temps pleinDe **HR-experten** van** Talentus** brengen jou in contact met je toekomstige werkgever. Deze gepassioneerde specialisten werken voor middelgrote Belgische ondernemingen. Zij maken er hun missie van om** jouw talent** te laten openbloeien in een job die je als gegoten zit. **Functie**: Als **QC Specialist** krijg je heel wat verantwoordelijkheden: - Als QC...
-
Customer Service Representative
il y a 2 jours
Leuven, Belgique 3D Systems Leuven Temps plein**ABOUT 3D SYSTEMS LEUVEN** 3D Systems Leuven 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 (production company). This makes us a strong innovation partner for clients in the industrial, medical and dental sector. With this technology, we...
-
Clinical Laboratory Quality
il y a 4 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...
-
3D Printing Operator
il y a 1 semaine
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...
-
Sales Operations
il y a 1 mois
Leuven, Belgique Materialise Temps pleinSales Operations & Data Specialist **Leuven, Belgium** **Sales & Business Development** **Hybrid** **Full-time** - The Sales Operations & Data Specialist works collaboratively with the sales team, management, and across departments to facilitate efficient operations for the sales team. You assist in managing different projects around sales enablement and...
-
Commodity Manager
il y a 2 jours
Leuven, Belgique 3D Systems Leuven Temps plein**About 3D Systems Belgium** 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 (production company). This makes us a strong innovation partner for clients in the industrial, medical and dental sector. With...
-
Manager Clinical Quality
il y a 1 mois
Leuven, Belgique Medpace, Inc. Temps pleinJob Summary: Responsibilities: **QEM Program activities** - Oversee and administer the QEM Program through maintaining Controlled Documents, Guidelines, Templates and associated training for Medpace staff - Develop and maintain a proficient, user-friendly QEM system - Provide training to QERM Office team members i.e. Clinical Quality and Risk Management...
-
Production Planner
il y a 1 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...
-
Payroll Specialist
il y a 4 semaines
Leuven, Belgique SD Worx Jobs Temps plein**Introductie**: Are you ready to shake up the payroll game? Join us as a Payroll Specialist for White Collar Employees and be at the forefront of a revolutionary payroll transformation. We're not just a team; we're passionate owners on a mission to turn challenges into opportunities. We dream big, brew iconic beers, and create meaningful moments. Let's...
-
QA Specialist
il y a 4 semaines
Leuven, Belgique GC Europe Temps pleinDie GC Corporation wurde 1921 in Japan gegründet und hat sich zu einem der führenden Unternehmen in der Entwicklung, Herstellung und dem Vertrieb einer sehr breiten Palette von Dentalprodukten entwickelt. Seit 1972 befindet sich unser europäisches Head Office GC Europe NV in Leuven, Belgien. Zur GC-Gruppe gehören innerhalb Europas einige...
-
Manufacturing Engineering Manager
il y a 1 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...
-
Datashift - Data Quality Consultant
il y a 17 heures
Leuven, Belgique Datashift Temps pleinFor one of our fastest growing practices we are looking for a Data Quality Consultant. Do you have 2 to 5 years of experience of which at least 2 to 3 years in the field of data analysis and/or data quality? And the prospect of helping to grow a company that believes in together creating an impact with Data at our customers sounds good?? Then we are...
-
Development Manager
il y a 4 semaines
Leuven, Belgique NXP Semiconductors Temps plein**The future starts here! Ready to start within Personal Health at NXP?** Following the success of our Product Line, we are expanding our team and are looking for a Development Manager - System and Digital. **Your responsibilities** The Development Manager leads competence teams or groups, and continuously assesses, builds, maintains and improves the...
-
Medior QA Test Specialist
il y a 5 jours
Leuven, Belgique IMEC Inc. Temps pleinComputer and IT - Leuven | Just now- In collaboration with the agile test team you will facilitate interoperability between different (health) systems on the Belgian market and guard quality of these systems.- In collaboration with the agile test team you will facilitate interoperability between different (health) systems on the Belgian market and guard...