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Quality Engineer (m/f)

SIRE Life Sciences®

Germany, zagranica

SIRE Life Sciences®

Quality Engineer (m/f)

Location: Germany

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 Niedersachsen Germany.

Our client is a fast growing medical device company focused in developing and producing wound care and medical devices class III products.

ROLE DESCRIPTION

In order to continue to meet the challenging demands and to establish a healthy growth, we are looking for a Quality Engineer to start as soon as possible.

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, and Lean Management (Six Sigma)
- 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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SIRE Life Sciences®

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