Senior Quality Assurance Officer

JR United Kingdom; Doncaster; On-site; GBP 45,000 - 60,000; Full time

Job summary

Une entreprise située à Doncaster recherche un Senior Quality Assurance Officer pour une durée de 12 mois, afin de couvrir un congé maternité. Ce rôle exige des connaissances approfondies des systèmes de qualité des dispositifs médicaux IVD et une formation en sciences ou domaine technique. Vous travaillerez sur des projets liés au développement et à la conformité réglementaire des produits.

Qualifications

• Expérience avec des dispositifs médicaux IVD et systèmes de qualité associés est essentielle.
• Poste implique responsabilité croissante en Assurance Qualité.

Responsibilities

• Supporter le développement de nouveaux produits et gestion du cycle de vie.
• Collaborer étroitement avec les affaires réglementaires pour les soumissions globales.

Skills

Connaissance des contrôles de conception

Développement de nouveaux produits en dispositifs médicaux

Systèmes de qualité IVD

Education

Baccalauréat en science, médical ou technique

Job description

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Senior Quality Assurance Officer, doncaster

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Client:

Jackson Hogg

Location:

doncaster, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

2

Posted:

04.06.2025

Expiry Date:

19.07.2025

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Job Description:

This temporary 12-month position (for maternity cover) reports to the Manager of Quality Assurance (Design) and is part of the Quality Assurance and Regulatory Compliance Department located in Newcastle-upon-Tyne and will be an on-site position.

In this role, you will have the opportunity to:

• Work on site projects to support the progression of the most viable commercial/strategic opportunities for New Product Development (NPD) or Product Lifecycle Management (PLCM)
• Plan, organise and conduct duties related to design assurance and ensuring executions of tasks ensuring the delivery to the business is within budget and on schedule
• Work closely with Regulatory Affairs on deliverables for global regulatory submissions, including FDA 510(k)s and PMAs and IVDR CE certifications

The essential requirements of the job include:

• Working knowledge of design controls for regulated products
• Experience in IVD medical device new product development and design controls
• Extensive knowledge of international IVD medical device quality systems including but not limited to 21 CFR 820 and ISO 13485
• Bachelor’s degree in science, medical or technical field and experience with increasing responsibility in medical device Quality Assurance

It would be a plus if you also possess previous experience in:

• Experienced with higher classification IVD/Medical devices and companion diagnostics
• IVD medical device regulatory affairs experience a distinct advantage