SIRE Life Sciences®

Senior QMS Expert

Location: Belgium

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 Brabant Flamand Belgium.

They are a start-up company focused in Ophthalmic devices. They grow every year with their revolutionary new device and due to this growth they are looking for a specialist to take responsibility over the QMS and RA Compliance.

ROLE DESCRIPTION

The new Senior Manager Quality Management Systems will be responsible and have authority over the Quality Management and QMS, how it is implemented, maintained and improved. You will supervise and manage the quality group to achieve compliancy to regulations and objections are fulfilled in the most efficient way.

RESPONSIBILITIES

As the new Senior Manager your responsibilities are to ensure compliancy with ISO 13485, FDA and EU Medical Device Regulations that you will achieve that with the Quality team that you supervise. You will as well be responsible for:
• Constant Assessment of the QMS in relevance to the Company strategy, organization and values
• Reporting the effectiveness of the QMS to top management and report issues or any need of improvement
• Ensure awareness and promotion of regulatory requirements and QMS requirements.
• Ensure that the working processes under which the devices are manufactured are in accordance with the QMS and find ways to increase efficiency or improvement
• Establish budget contributing for the funding of the Quality function

REQUIREMENTS

• Knowledge of ISO 13485, FDA, EU Medical Device Regulations
• A minimum of 5 years of experience in QA/RA
• A certified ISO 13485 internal auditor
• Proven experience with inspections and interactions with competent authorities
• High level administration and organizational/planning skills

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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SIRE Life Sciences®

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