Senior Quality Assurance Officer

JR United Kingdom; Hemel Hempstead; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading company in the medical device sector is seeking a Senior Quality Assurance Officer for a temporary 12-month position covering maternity leave. This role involves ensuring compliance for new product development and collaboration with regulatory affairs to meet global submission standards. Candidates should have a strong background in design controls and IVD medical device quality systems.

Qualifications

• Working knowledge of design controls for regulated products.
• Experience in IVD medical device new product development.
• Extensive knowledge of international IVD medical device quality systems.

Responsibilities

• Support projects for New Product Development (NPD) and Product Lifecycle Management (PLCM).
• Conduct design assurance duties ensuring budget and schedule compliance.
• Collaborate with Regulatory Affairs on global regulatory submissions.

Skills

Design controls

IVD medical device development

Quality systems

Education

Bachelor’s degree in science, medical or technical field

Job description

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Senior Quality Assurance Officer, hemel hempstead

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Client:

Jackson Hogg

Location:

hemel hempstead, 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