QA Specialist
1 week geleden
NES Fircroft is looking for a QA/RA specialist to join an high-end technology supplier specializing inmedical technology, biotechnology, and in-vitro diagnostics. Our client provide contract engineering and manufacturing services, covering the entire product development process from concept to production.Responsibilities Ensure compliance with international regulatory standards (e.g., ISO 13485, MDR, FDA 21 CFR Part 11) for medical devices. Develop, implement, and maintain Quality Management System (QMS) processes and documentation. Prepare and submit regulatory filings, technical documentation, and product registrations. Conduct internal audits and support external audits from notified bodies and regulatory authorities. Monitor and interpret changes in relevant regulations and standards, ensuring timely implementation. Collaborate with cross-functional teams (R&D, Manufacturing, Clinical) to ensure regulatory and quality requirements are met throughout the product lifecycle. Manage risk assessments, CAPA (Corrective and Preventive Actions), and non-conformance reports. Support product labeling, IFU (Instructions for Use), and compliance with UDI requirements. Provide training and guidance on quality and regulatory processes to internal teams. Requirements Bachelor’s or Master’s degree in Biomedical Engineeringor similar. Minimum 2–3 years of experience in QA/RA roles within the MedTech or medical device industry. Strong knowledge of ISO 13485, EU MDR, and FDA regulations. Experience with QMS implementation and maintenance. Excellent documentation and organizational skills. Proficiency in English (written and spoken); additional languages are a plus.
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QA/RA Specialist
1 week geleden
Delft, Nederland NES Fircroft VoltijdNES Fircroft is looking for a QA/RA specialist to join an high-end technology supplier specializing in medical technology, biotechnology, and in-vitro diagnostics . Our client provide contract engineering and manufacturing services, covering the entire product development process from concept to production. Responsibilities Ensure compliance with...
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QA/RA Specialist
1 week geleden
Delft, Nederland NES Fircroft VoltijdNES Fircroft is looking for a QA/RA specialist to join an high-end technology supplier specializing in medical technology, biotechnology, and in-vitro diagnostics. Our client provide contract engineering and manufacturing services, covering the entire product development process from concept to production.Zorg ervoor dat u de informatie over deze vacature...
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QA/RA Specialist
1 week geleden
Delft, Nederland NES Fircroft VoltijdNES Fircroft is looking for a QA/RA specialist to join an high-end technology supplier specializing in medical technology, biotechnology, and in-vitro diagnostics . Our client provide contract engineering and manufacturing services, covering the entire product development process from concept to production. Responsibilities Ensure compliance with...
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QA/RA Specialist
1 week geleden
Delft, Nederland NES Fircroft VoltijdNES Fircroft is looking for a QA/RA specialist to join an high-end technology supplier specializing in medical technology, biotechnology, and in-vitro diagnostics . Our client provide contract engineering and manufacturing services, covering the entire product development process from concept to production. Responsibilities Ensure compliance with...
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QA/RA Specialist
1 week geleden
Delft, Nederland NES Fircroft VoltijdNES Fircroft is looking for a QA/RA specialist to join an high-end technology supplier specializing in medical technology, biotechnology, and in-vitro diagnostics. Our client provide contract engineering and manufacturing services, covering the entire product development process from concept to production.Zorg ervoor dat u de informatie over deze vacature...
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QA/RA Specialist
1 week geleden
Delft, Nederland NES Fircroft VoltijdNES Fircroft is looking for a QA/RA specialist to join an high-end technology supplier specializing in medical technology, biotechnology, and in-vitro diagnostics . Our client provide contract engineering and manufacturing services, covering the entire product development process from concept to production. Zorg ervoor dat u de informatie over deze vacature...
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QA/RA Specialist
2 weken geleden
Delft, Zuid-Holland, Nederland NES Fircroft Voltijd € 45.000 - € 75.000 per jaarNES Fircroft is looking for a QA/RA specialist to join an high-end technology supplier specializing inmedical technology, biotechnology, and in-vitro diagnostics. Our client provide contract engineering and manufacturing services, covering the entire product development process from concept to production.ResponsibilitiesEnsure compliance with international...
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QA Officer
1 week geleden
Delft, Zuid-Holland, Nederland 2M Recruitment VoltijdWil jij bijdragen aankwaliteitsborging binnen een internationale organisatiedie duurzame voeding mogelijk maakt?Voordsm-firmenichinDelftzoeken wij eenQA Support Specialistdie zorgt voor structuur, compliance en documentatie binnen hetQuality Excellence-team.Je werkt aan eennauwkeurig en toekomstgericht kwaliteitsprocesin de petfooddivisie van een...
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QA/RA Specialist
1 week geleden
Delft, Nederland NES Fircroft VoltijdNES Fircroft is looking for a QA/RA specialist to join an high-end technology supplier specializing in medical technology, biotechnology, and in-vitro diagnostics. Our client provide contract engineering and manufacturing services, covering the entire product development process from concept to production.Zorg ervoor dat u de informatie over deze vacature...
