Senior Quality Assurance Officer

JR United Kingdom; Milton Keynes; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading company is seeking a Senior Quality Assurance Officer in Milton Keynes for a temporary 12-month role supporting new product development and regulatory compliance. Key responsibilities include design assurance and collaboration with regulatory affairs for IVD medical devices. Candidates should possess a relevant degree and substantial quality assurance experience.

Qualifications

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

Responsibilities

• Support new product development and regulatory submissions.
• Plan and conduct design assurance tasks within budget and schedule.
• Collaborate with Regulatory Affairs on global submissions.

Skills

Design controls for regulated products

IVD medical device development

Quality systems knowledge

Education

Bachelor’s degree in science, medical or technical field

Job description

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Senior Quality Assurance Officer, Milton Keynes

Client: Jackson Hogg

Location: Milton Keynes

Job Category: Other

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EU work permit required:

Yes

Job Views:

2

Posted:

04.06.2025

Expiry Date:

19.07.2025

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. It 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, organize, and conduct duties related to design assurance, ensuring tasks are executed within budget and on schedule.
• Work closely with Regulatory Affairs on deliverables for global regulatory submissions, including FDA 510(k)s, 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, with experience in medical device Quality Assurance with increasing responsibility.

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

• Higher classification IVD/Medical devices and companion diagnostics.
• IVD medical device regulatory affairs experience.