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QA Specialist
Sunstar - Etoy
12.07.2019 | Employee | 100%

Sunstar offers products and services to customers in more than 90 countries around the world. In all of our business fields, we strive to create unique, useful, and attractive products and services that help people around the world attain the key social values of Health, Beauty, Comfort and Safety. All of our corporate activities are aimed at helping people fulfill their aspirations to lead healthier and happier lives.

 

For our entity Sunstar Suisse SA based in Etoy (Morges/St. Prex area), we are looking for a

QA Specialist

The incumbent will be responsible for providing control over quality for all Sunstar Suisse SA and Sunstar Europe products to ensure that the appropriate standards for quality (including but not restricted to ISO 9001 and ISO 13485) are maintained to reach customer’s reliability. The jobholder will be responsible for the following accountabilities:

 

Global Quality Assurance for Sunstar Suisse SA:

 

·  Support Sunstar Suisse SA processes from a Quality standpoint

·  Performs other related duties as assigned

 

EMEA Quality Assurance for Sunstar Europe SA:

 

  • Support Sunstar Europe SA processes from a Quality standpoint:
  • Document and Record Control, in particular write and/or review SOP, WKI, FORM for Quality-related processes and support other departments in regard to the writing and/or review of the SOP, WKI and FORM for other processes
  • Management Processes, in particular the compilation of relevant information and the preparation of management reviews and quality objectives
  • Internal Communication on quality-related matter
  • Human Resources Management, in particular the support of Quality-related program
  • Supplier Lifecycle, in particular the identification and assessment of quality-related requirements, as well as the monitoring of suppliers
  • Design & Development, in particular the coordination of change management and the support from a quality standpoint to design & development projects
  • Verification Activities
  • Customer-Related Process, in particular regarding enquiries management
  • Product Identification & Traceability
  • Logistic, Storage and Preservation
  • Equipment & Infrastructure Management, in particular for Monitoring and Measuring devices
  • Audit Management, for internal and external auditing activities
  • Performance/Analysis of Data
  • Performs other related duties as assigned

EDUCATION

  • University degree
  • Training on ISO 9001 and ISO 13485 standards
  • Fluent in English (both written and spoken)
  • Computer literacy: MS Office
  • Training on regulations regarding life science/healthcare products (EU, US and/or Japan for pharmaceuticals, medical devices and/or cosmetic products)

EXPERIENCE

  • 3-5 years’ experience in technical and quality affairs with interpretation and application of standards/current industry practices
  • Experience in supplier auditing / inspection
  • Experience in internal auditing
  • Experience in project management as project team member
  • Experience in life science/healthcare products
  • Experience in project management as project manager

COMPETENCIES

  • Analytical skills
  • Strong interest in technical affairs regarding production and quality control
  • Full capacity to objectively assess the product quality
  • Ability to independently identify compliance risks and escalate when necessary
  • Problem solving skills
  • Autonomous
  • Project management skills
  • Basic knowledge in Japanese

AVAILABLE

Immediately

If you want to take on this challenge, please apply through our website only (http://www.sunstar.com/company/careers) under the Sunstar Suisse SA section

We look forward to receiving your application.

HR Department

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