Requirements

Required education level
Ad. Federal PET / Fed. PET Diploma, Bachelor, Master
Required experience
Between 3 and 5 years
Required language knowledge
English German

Details

Location
Other countries
Term of employment
Full time
Sector
Biotechnology / chemistry / ph...
Professions
Regulatory Affairs Biology / Biotechnology Chemistry Management / Project Managemen... Pharmaceuticals Pharmacy / Drogstore Production Research & Development / Labor...

Description

* Quality Engineer * Austrian MedTech * Global leader In Vitro Diagnostics * German essential *

Here is a leader in the Diagnostics sector developing and manufacturing medical devices globally. Currently seeking a Senior Quality Engineer for their Austrian site to work closely with R&D ensuring Design Assurance and Quality compliance, and in general to take responsibility for product and process quality in projects, and supporting and monitoring the project teams (areas risk management, verification, derivation of test plans, first-level documentation review, change management)

Other responsibilities to include

  • Monitoring and ensuring compliance with regulatory requirements
  • Support of the interdisciplinary development team in statistical experimental design and technical documentation
  • Creation and training of process documents
  • Multi-site collaboration internationally in international research and development projects
  • Audit Support

Ideally this role would require a degree qualified QA professional with 5+ years experience industry experience in implementing regulatory requirements to ISO 13485 in the product development environment, however people with more operational quality backgrounds are invited to apply as strong DA skills are present on site. Previous IVD experience is a plus, at least a knowledge of ISO 13485 is essential. Pharma or Chemical or even Foods ie other tightly regulated industry backgrounds will be considered. German is essential for this role, with English being the company wide language internationally

This is a new role with an ideal start date of September, but negotiable at both ends, and interviews will be organised at short notice.

For more information on this vacancy, please contact the Senior Consultant Andrew Boroky on 0041 43 50 80 816, and email him at quality@quality-devices.com ahead of a confidential discussion of this opportunity. For industry news and new opportunities in QA within the Medical Devices & Diagnostics sectors, please also join my Linked group ch.linkedin.com/in/qaswitzerland/en

KEY WORDS: Quality Assurance, QA, Design Assurance, Compliance, Auditor, Medical Devices, Austria, Switzerland, ISO 13485, ISO 9001, ISO 14971, GMP, CAPA, Corrective action, preventative action, Production, Manufacturing, Medical Device jobs, nonstop recruitment

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

NonStop Recruitment
Sep 10, 2019

Contact info

NonStop Recruitment
Andrew Boroky
10w yw y- z7 )y( 07g
Not available