QA/ra & Qs Officer
Il y a 7 mois
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**:
In 2020, **Quirem Medical** B.V. was acquired by **Terumo Corporation**. As a result of the acquisition, Quirem Medical B.V. became part of the Terumo Therapeutic Interventional Oncology (TIO). TIO offers fully integrated solutions for treating liver cancer through radioembolization, chemoembolization and ablation. _In our site in _**_Deventer_**_, the Netherlands, our associates are involved in Production, R&D, Clinical & Medical, QA, RA, Supply Chain and Support Services._
**Job Summary**:
- The Quality Assurance & QS Support Officer is responsible for maintaining and improving the efficiency and compliance of the Quirem quality management system - including preparing or updating necessary procedure and documentation.
- Monitoring industry developments and assessing business impact. Prepare trend reporting.
- Assuring Quality & Regulatory compliance in product and process development and change projects.
- Take the lead in investigating and coordinating initiatives to improve the quality and manufacturing efficiency of Quirem products.
- Takes the lead in investigating and coordinating CAPA and customer complaints.
**Responsibilities**:
- Provide guidance, training, as well as hands on support in the review, development and approval of new documents, procedures, and changes to existing procedures, processes, plans, and other quality system (QS) documentation. Look for QS possibilities for improvement.
- Helps to keep the quality system up to date by controlling the QMS documents overview and trigger regular reviews. For achieving such, cooperates with QARA team members and where required / requested with the rest of the organization.
- Closely follow up applicable legislation and standards for the Quirem Medical products in the EMEA market and assess business impact.
- Manage follow-up on Corrective and Preventative Actions (CAPA) and customer complaints. Investigate and report on progress and status.
- Manage and execute (or assist in) supplier & internal audit program and audits and manage & assist in notified body audits. Write audit reports where applicable.
- Obtain input for and issue monthly QA/RA reporting, MT-extended meeting input, management review input.
- Review & approve production batch records. Verify QA data in Qnack (ERP system) for e.g. order release etc.
- Makes sure the Supplier audit program is executed, timely and reports on the progress, the completeness and quality of the program.
**Profile Description**:
- BSc (or higher) degree or equivalent (preferably in pharmacy, biotech, chemistry, toxicology)
- Working experience (>5 years), preferably in the process industry for medical devices, pharmacy, biotechnology, (bio)chemistry, food or comparable
- Minimum 3 years of experience in a Quality or Regulatory Affairs function in the medical device or pharmaceutical industry or >3 years in food/feed or (bio)chemicals industry
- Knowledge of ISO13485 and MDR requirements
- Excellent interpersonal and communication skills
- Team player
- Accurate and precise
- Analytical skills
- Good control of the English language, written and verbal
**Offer**:
We offer a very challenging role within this pioneering division of Terumo. You play an active role to launch our products on a global level, and as such give patients access to our technology to improve the quality of their lives.
You can count on a competitive salary and extra benefits, coaching by your manager and colleagues, and access to a vast amount of training content to develop yourself in a professional way.
**Contact Person**:
Peter Coolen
Talent Acquisition Partner
- 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._
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