Quality Assurance Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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About MedTech

Motivated by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are looking for the best talent for a Quality Assurance Specialist to be in Nijmegen, Netherlands

If you fit this description, we invite you to become part of our growing QA department, where you will play a key role in documenting, supporting, and ensuring that our products meet the high-quality standards established by the company.

This position is with GATT Technologies, founded in 2011 and located in Nijmegen, The Netherlands. GATT is at the forefront of innovation, introducing next-generation hemostats and sealants that have the potential to transform the future of surgery.

You will be responsible for:

• Drive the Quality Management System (QMS) to excel in compliance with ISO 13485, ISO 14971, and FDA 21 CFR Part 820 while upholding Document Control through Good Documentation Practices and Data Integrity.

• Collaborate on quality assurance procedures and leverage GMP expertise to improve quality processes, ensuring we meet and exceed industry standards.

• Coordinate and lead quality documentation, facilitate seamless uploads in the electronic QMS (eQMS), and review crucial quality records, supporting ongoing development through training documentation.

Qualifications/requirements:

• We are looking for a hard-working candidate with a diploma from a university or technical college, preferably holding a Bachelor’s degree in engineering or a relevant scientific field, such as pharmaceutical sciences or biochemistry.

• Experience in the medical device industry and familiarity with ISO 13485 and MDR regulations are advantageous.

• A positive “can do” demeanor and strong organizational skills. You should be able to work well in a team and communicate efficiently.

• Attention to detail and proactive problem-solving abilities are crucial.

• NC's and CAPA knowledge is needed

• Proficiency in English is required, and knowledge of Dutch is a plus.

*please not that we are currently not able to progress with any candidates outside of the NL region for this role.

Ready to take the next step? Apply now! #RPOAMS