QA Specialist Medical Devices
Location: BelgiumSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Medical Devices organisation, based in Oost-Vlaanderen Belgium.
- Negotiate Quality agreements with third parties like manufacturers, service providers and other distributors
- Support integration of new product introductions, technical transfers and validations/qualifications
- Investigating quality incidents, deviations, complaints and follow up CAPA's and supplier improvement plans
- Team support in data and document collections for regulatory purposes and ensuring ongoing inspections
- 3+ Yrs, relevant experience in Quality Assurance or Production
- Knowledge of EU Medical Device Directive or EU Medical Device Regulation
- Knowledge of ISO13485, knowledge of ISO14971 and other standards are seen as an asset
- Manufacturing process experience of solid, semi-solid liquid formulations
- Fluent in English, extra European Language is a plus
- Willing to travel
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Fernand Voortjes.
The Company
This company is one of the biggest companies with the focus in consumer health. They are dedicated to making lives better in diverse industries.Role Description
As a Quality Assurance specialist Medical Devices you will be part in many internal and external processes. You will be the representative and you will support the business needs in the area of Medical device QA. It also includes new product launches and introductions. As QA specialist you will be in charge for external supplier contracts and the implementation of new MDR/MDD. You see options for improvement and will localize gaps in all processes.Responsibilities
- Be the QA representative within certain product portfolio and be responsible over it- Negotiate Quality agreements with third parties like manufacturers, service providers and other distributors
- Support integration of new product introductions, technical transfers and validations/qualifications
- Investigating quality incidents, deviations, complaints and follow up CAPA's and supplier improvement plans
- Team support in data and document collections for regulatory purposes and ensuring ongoing inspections
Requirements
- Master Degree in Pharmaceutical or Biomedical field- 3+ Yrs, relevant experience in Quality Assurance or Production
- Knowledge of EU Medical Device Directive or EU Medical Device Regulation
- Knowledge of ISO13485, knowledge of ISO14971 and other standards are seen as an asset
- Manufacturing process experience of solid, semi-solid liquid formulations
- Fluent in English, extra European Language is a plus
- Willing to travel
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Fernand Voortjes.
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