Consultant Quality Assurance / Validation

ref: 32346


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 Noord-Brabant Netherlands.
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. 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 (CSV)
- Can do mentality
- Commitment for longer period of time
- Handson experience

Secondary benefits

  • Laptop
Country
Netherlands
Region
Noord Brabant
Sector
Medical Devices
Specialization
Quality, Regulatory Affairs, Continuous Improvement
Employment type
Freelance
Experience
> 10 Years
Education
Master
Location type
Multiple locations
Salary
Negotiable - Negotiable
Language
English, Dutch