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05.09.2016

Freelance Quality Assurance Engineer

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Medical Devices organization, based in Germany.

Our Client a fast growing and innovative medical device company focused on cardiovascular products located in the Munich area.

ROLE DESCRIPTION

To support the local quality team we are looking for a Freelance Quality Assurance Engineer (m/f) for a timeframe of 4 months starting the latest the 1. of April. The Position is located in the Munich area, home-base is an option at a later stage.

RESPONSIBILITIES

-Develop and execute the regulatory affairs strategies and procedures for existing and new products for worldwide product registration including Product Master Files (PMF)
-File and document DIMDI Notifications, Recalls, MDD Vigilance, PSUR Reports and annual reports
-Coordinate with product development including the process validation and verification including Design Control
-Support quality team with Quality and overlapping topics such as risk management, packaging, labelling, CAPA, etc…
-Support with the internal and external audits

REQUIREMENTS

-Minimum a Bachelor’s degree preferable in Medical Engineering or another Life Science field
-Alternatively have demonstrated relevant experience in the field of quality in Medical Devices
-A min. 3-5 years’ experience in quality dealing with medical devices class III
-Experience in cardiovascular implants and products as well as drug devices are advantageous
-Excellent knowledge in the relevant ISO’s including ISO 13485, 14971 and ISO 10993
-A good understanding of Regulatory requirements
-Team player with outstanding interpersonal and communication skills and integrative thinking
-Fluent in English and German

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Matthias Kunkel.



 
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