Teijin
 
Teijin Aramid Arnhem Contact Lijnske Boogaarts
 
 
Delen Tools

 
29-05-2019

Quality Assurance Officer

The Solution 2.0 of Teijin is looking for a ​Quality Assurance Officer
analytical, responsible, initiative and accurate
 
As Quality Assurance Officer you are responsible for establishing and maintaining our Quality Management System (QMS). You will establish ISO 13485:2016 and ISO 9001:2015 certified system for new business(s) and product(s). This challenging role requires a combination of a good knowledge  quality management and the value chain used in the specific business environment. Your primary workplace is in Arnhem. You report to Director New Business and work together with the New Business Development Manager. Your primary workplace is situated in Arnhem, The Netherlands.
 
Your key responsibilities:
  • Setup/Support of a Process oriented QMS over the Life Cycle of a Medical Device;
  • Implement principles of general QMS Documentation, Document Control and Record Management;
  • Drives Continuous Improvement Process, Internal Error Reporting and Management, Customer Complaints and Risk management;
  • Corrective and Preventive Actions (CAPA), Reporting Process to Competent Authorities and Notified Bodies;
  • Check performance of the QMS.
Your profile
To be successful in this role you have a bachelor degree, preferably, in engineering and at least 5 years’ experience in QMS for Medical Devices or other fields. Furthermore you have;
  • Ability to structure and setup an ISO 13485:2016 based QMS in cooperation with other QMS managers within Teijin, implement QMS and train the organization  to adhere to its processes, procedures and documentation;
  • To measure the performance and report to Management Team;
  • Good understanding for General Principles of a QMSQ and Requirements Management systems in the Medical Device Industry in organization;
  • Detailed knowledge on Structure, Scope and Applicability of ISO 13485:2016 & ISO 9001:2005;
  • To understand Legal and Regulatory Framework for Medical Devices.
 Detailed knowledge of:
  • The Legal and Regulatory Framework for Medical Devices and ISO 13485:2016;
  • Relevance/Applicability of ISO 13485:2016 in European Conformity Assessment;
  • Relationship MDR/IVDR and ISO 13485:2016;
  • Applicability ISO 13485:2016 to requirements 21 CFR Part 820;
  • Similarities/differences between ISO 13485:2016 and ISO 9001:2015;
  • Resource Management, Training and Performance Measurement;
  • Basic Principles in Measurement/Verification;
  • Process Control for Medical Products: Knowledge of SPC and process validation;
  • Requirements for measuring devices and their management;
  • Principles of  Q-Methods and Q-Tools.
 Personal skills
• Self-motivated, independent, flexible, entrepreneur, motivating technical experts;
• Capable of working in a dynamic environment;
• Team player with excellent interpersonal, communication and presentation skills;
• Capable to work effectively in a matrix organization;
• Fluent in English, Dutch and other languages basic;
• Sense of humor!

What we offer
The employment contract will be a definite period contract for a year with Teijin Aramid. Further, other constructions for a definite period are also possible. In addition to a challenging, varied job and inspiring international work environment, we offer an excellent employment package:
  • Work at a global leading company in the supply of high-performance aramid fiber;
  • As the 25% best paying employers in the Netherlands a great salary package;
  • ‘Personal Budget of Choice’  - you e.g. can add to your 20 vacation days at least 26 more;
  • The possibility of working from home & flexible working hours for a healthy work-life balance;
  • Job and career development at our own Teijin Aramid Academy;
  • Good pension scheme. 
The  Solution 2.0 Department
The Solution 2.0 department has been initiated to be the growth engine for the transformation of Teijin Group. The focus is on the end-user perspective and to create, deliver and capture value via new business models. Solutions are developed by leveraging the full portfolio and competences across the Teijin Group in cooperation with start-ups, established companies and institutions. Solution 2.0 is a global team operating worldwide from offices in The Netherlands and Japan. The department reports directly into the Teijin’s Material Business Group.

Total HealthTec Solution Platform (THSP) Europe
As a part of the Teijin’s transformation strategy, Teijin has the mission to establish cutting-edge business platform(s) addressing the demographic change and increased health consciousness solutions to the society. For this purpose Teijin has developed THSP strategy focusing on expanding horizons from disease to pre-symptomatic care. Under the umbrella of  Teijin’s global materials and healthcare new business strategy, Teijin (Solution 2.0) is leading the development and commercialization of Teijin’s Healthtec solutions in Europe. THSP focus on minimal interventional medical devices (Cardio-vascular market), Functional food & Digital solutions. This will improve the healthy living and ageing of the society.

Information and application
For more substantive information, please contact Mukund Tiwari, New Business Development Manager at tel. +31 (0)6 5219 9574 or Mary Zwartkruis, for questions about the process HR Officer at tel. +31 (0) 88-268 9143. We would like to receive your application via the application button. An assessment may be part of the application procedure.
 
The company
Teijin is a technology-driven global group offering advanced solutions in the areas of environmental value; safety, security and disaster mitigation; and demographic change and increased health consciousness. Its main fields of operation are high-performance fibers such as aramid, carbon fibers & composites, healthcare, films, resin & plastic processing, polyester fibers, products converting and IT. The group has some 170 companies and around 19,000 employees spread out over 20 countries worldwide. More information you find on https://www.teijin.com/




Keywords
Lead Auditor, Kwaliteitsmedewerker, Adviseur Kwaliteit, Kwaliteitscoordinator, Quality Consultant, Assessor, Beoordelaar, Auditor, Certification Engineer, Kam Coordinator, Quality Engineer, HBO


 

 

Vacature @ update

Ontvang vergelijkbare vacatures per e-mail.

Heb je al een account? Inloggen
E-mail  
Bewaar zoekopdracht als

Vacature @ update

Ontvang vacatures van dit bedrijf per e-mail.

Heb je al een account? Inloggen
E-mail  
Bewaar zoekopdracht als