Senior Quality Assurance Officer

JR United Kingdom; Kingston upon Hull; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading company in quality assurance is seeking a Senior Quality Assurance Officer for a 12-month maternity cover role in Kingston upon Hull. This on-site position involves essential responsibilities in new product development and design controls for IVD medical devices, ensuring compliance with stringent regulatory standards. Ideal candidates will have a strong background in medical device quality systems and a bachelor's degree in a relevant field.

Qualifications

• Experience with IVD medical device quality systems.
• Increasing responsibility in medical device Quality Assurance.
• Experience in regulatory submissions (FDA 510(k)s, PMAs).

Responsibilities

• Support progression of commercial opportunities for NPD or PLCM.
• Plan and conduct design assurance duties.
• Work closely with Regulatory Affairs for global submissions.

Skills

Working knowledge of design controls

Understanding of IVD medical device quality systems

Experience in new product development

Education

Bachelor’s degree in science, medical, or technical field

Job description

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Senior Quality Assurance Officer, kingston upon hull, east yorkshire

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Client:

Jackson Hogg

Location:

kingston upon hull, east yorkshire, 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