Quality Assurance Specialist
Comate, Belgium
Job Description
Do you want to help build tomorrow’s world? Welcome to Comate, where we develop innovative high-tech hardware from scratch for pioneering companies across all possible industries: from the most secure cryptowallet on the market and a design snowplough to a device that makes hip surgery more efficient for surgeons and patients alike. Our robots, IoT devices and other high-tech products have already won dozens of international awards. In 2019, we were voted SME of the year.
We currently are looking for talented and passionate engineers and designers like you, who can develop new, disruptive products together with our clients. Do you only strive for excellence and do you want to grow your career in step with our company? Then perhaps you’re the M/F/X we’re looking for.
You will work within a multidisciplinary team of engineers and designers on the development of innovative products and machinery. The aim of our passionate team is to cooperate with our clients in order to develop a unique product that is more advanced than anything that is currently available on the market. As a Quality Assurance specialist you are driven by continuous improvement.
What does this mean?
You ensure that the Quality Management System requirements are effectively established and in accordance with applicable medical device regulations for Comate's Life Sciences related activities
You support engineering and product development projects for Life Sciences customers by providing expert input and know-how to the team of engineers and designers, and support the writing of the technical files and related documentation
You conduct internal audits and provide guidance regarding best practices and continuous improvement.
You support core quality systems including root cause analysis, CAPA, non conformance, chance control, and risk management, as well as control of documentation and records.
You coordinate external audits from notified bodies and customers. Follow up on any actions resulting from these audits.
Requirements
Sounds great! Am I the Quality specialist you are looking for? Let’s see:
You are passionate about all Quality related aspects in product development.
You have a higher degree in Engineering or Science.
You have work experience in a quality assurance and/or regulatory affairs role in a Life Sciences environment ( a focus on the development of medical devices is a plus ). Therefore you have a in depth understanding of a Quality Management System, and requirements for ISO 13485 and/or ISO 9001.
You know how to interpret and apply different regulations and compliance concepts.
You are very hands-on and pragmatic.
You are flexible, you have no problems with adapting new plans. Product development is fun, but also unpredictable.
You can handle pressure because honestly, we work hard.
Benefits
Why should you apply?
You will be joining a team of enthusiastic and passionate colleagues.
You will be working on the design and development of truly unique products and solutions, end-to-end. Yes, you can be an inventor! There is nothing more thrilling than seeing your work out there on the market.
Comate offers a broad portfolio of training and educational courses, allowing you to grow.
Comate is a fast-growing company, so you can grow with us and grow in your area of expertise or interest.
You will be able to work in a cool office right in the heart of the vibrant city of Leuven or Ghent.
You will get an attractive salary package with a lot of extra benefits.
And yes, Comate is an award-winning company! We want to excell in what we do, it’s no walk in the park but our hard work pays off.