QA Manager
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.
As you manage QA you will fulfil a key role in the strategy of the company from a QA perspective and advice the board how to proceed regarding the challenges the company walks into.
- Coordinating, Coaching and training Quality employees
- Improve Quality mindset and implement Change management where needed
- Liaise with different teams both local and global to achieve a high quality product
- Document and report with the board to advice on strategy
- Coordinate QA activities such as CAPA, document/design control, implementation of ISO 13485, Complaints handling etc.
- Implement and manage an incoming inspection team
- Perform internal and external audits
- At least 7 years of experience in a Medical or other highly regulated environment
- Knowledge of ISO 13485 and FDA 21 CFR 820 is a must
- Knowledge of IEC 60601 is a big plus
- Fluent in 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 Medical Device company providing life changing technologies around the world. They focus on vascular and Medical Electronic devices supporting a better and healthier life. Their team is now in need of a QA Manager to coordinate and manage all QA activities in EMEA form their headquarters in Utrecht.Role Description
As the QA Manager you will lead a team of 5 QA engineers and specialists. The QA Manager will coordinate the implementations of quality systems, find improvements and make sure corrective and preventive actions (CAPA) are taken. You be a part of the Management Team and document and report quality findings.As you manage QA you will fulfil a key role in the strategy of the company from a QA perspective and advice the board how to proceed regarding the challenges the company walks into.
Responsibilities
In this position you will have responsibilities such as:- Coordinating, Coaching and training Quality employees
- Improve Quality mindset and implement Change management where needed
- Liaise with different teams both local and global to achieve a high quality product
- Document and report with the board to advice on strategy
- Coordinate QA activities such as CAPA, document/design control, implementation of ISO 13485, Complaints handling etc.
- Implement and manage an incoming inspection team
- Perform internal and external audits
Requirements
- At least 5 years of experience in QA Medical Devices- At least 7 years of experience in a Medical or other highly regulated environment
- Knowledge of ISO 13485 and FDA 21 CFR 820 is a must
- Knowledge of IEC 60601 is a big plus
- Fluent in 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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