Quality Systems Specialist

il y a 3 jours

Leuven, Belgique Terumo Europe Temps plein

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 QS Specialist Doc Control & Training 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.

**Responsibilities**:
**In your role as QS Specialist you’ll be involved in the following main topics**:
**Quality Systems Audits**
- You’ll participate in the internal audits of Terumo Europe

**Training QMS process in Terumo Europe**
- You’ll maintain the training process and keep applicable procedures aligned with current standards and regulations.
- You’ll 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.
- You’ll review quiz assessments on QMS procedures.
- You’ll represent QS in Smartsolve board to assess to which learning plans new procedures should be linked.
- You’ll provide support to HR in maintenance of the e-QMS learning module.
- You’re 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.
- You’ll define and follow up on KPI’s to monitor the training process.

**Document management system in Terumo Europe**
- You’ll maintain the document/record control process and keep applicable procedures aligned with current standards and regulations.
- You’ll give training on document management system in e-QMS, technical writing of SOP’s and archiving of QMS records.
- You’ll supervise group of master file coordinators
- You’re responsible for measuring 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 of 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 with a Quality Management System is an asset (e.g. Smartsolve, Veeva,)
- Experience as (internal) auditor as a preference
- Good working knowledge of English (written and spoken).
- Able to work independent, proactive, eager to solve issues
- Team player with strong communication skills to collaborate with a large variety of stakeholders (IT, HR,)
- 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

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