QA/RA Specialist
Location: NetherlandsSIRE® 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 Utrecht Netherlands.
- Implementing improvements and CAPA's, and solve NC's when found
- Train and coach colleagues if necessary to increase Quality Mindset/Change Management
- Support and/or lead audits
- Perform Risk analysis
- Give sound advice to Management Team on how to proceed strategy for product marketing from a QA standpoint
- Support when/if necessary RA team
- Documentation of QA activities and changes
- At least 3 years of experience in Quality Assurance
- Experience with ISO 13485 and ISO 9001, FDA 21 CFR 820 is highly preferred for this position
- Audit experience
- Speak fluent Dutch and English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jeroen Evertsen.
The Company
They are an international manufacturer and distributor specialised in healthcare and diagnostic medical devices. They have international partners and distributing products especially to America. This brings a lot of challenges on a quality perspective and since their demand is growing they are now in need of a Quality Specialist to support the team.Role Description
As the QA Specialist you will support the QA team in the new projects that will start in 2018. Here you will develop the Quality Systems based on the ISO 13485 standard for their new product(s) and find improvements in the QMS. Since the company has a lot of business in America you will be working with American partners, FDA agencies and audits, support certification of FDA regulations and with the team achieve a certified products to market in both Europe and America.Responsibilities
- The development of the Quality Management Systems of current and new products- Implementing improvements and CAPA's, and solve NC's when found
- Train and coach colleagues if necessary to increase Quality Mindset/Change Management
- Support and/or lead audits
- Perform Risk analysis
- Give sound advice to Management Team on how to proceed strategy for product marketing from a QA standpoint
- Support when/if necessary RA team
- Documentation of QA activities and changes
Requirements
- At least 4 years of experience in Medical Device industry- At least 3 years of experience in Quality Assurance
- Experience with ISO 13485 and ISO 9001, FDA 21 CFR 820 is highly preferred for this position
- Audit experience
- Speak fluent Dutch and English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jeroen Evertsen.
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