Consultant QA & RA Medical Devices

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 Healthcare and Medical Devices organization, based in Limburg Netherlands.

Medical Device company with its headquarters in the Netherlands.

ROLE DESCRIPTION

The company is looking to hire a consultant with Quality Medical Device experience for at least six months. Highly likely to be 12 months or even more. My client is currently occupied with a project which contains the streamlining of the different operating quality management systems within the company. Multiple projectteams are doing an inventory, building a new, or validation a new QMS. In this stage the company is looking for a Q&R person with medical device experience, and experience in reviewing and redesigning processes. Work with program and project teams from the business and Q&R to perform the review and incorporation of Quality System Regulations into the processes down to the level of work instructions.

RESPONSIBILITIES

- Create and write Quality Plan in collaboration with the different teams and Q&R department
- Defining the needs of the renewed Quality Management Systems
- Support of the overall program
- Supporting the GAP-analysis
- Supporting the projectteams
- Alignment between the Quality Plans, Verification & Validation Plans and deployment Plans

REQUIREMENTS

- 10 years plus experience in Medical Devices QA/RA
- Knowledge of FDA CFR 820, ISO 13485 medical devices regulations
- Expert on Quality Systems matters
- Software validation
- Validation skills (IQ,OQ, PQ)
- Can do mentality
- Commitment for longer period of time
- Handson experience

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