Senior Quality Assurance Officer

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

Job summary

A leading company is seeking a Senior Quality Assurance Officer for a temporary position in Luton, UK. This role involves supporting New Product Development and ensuring compliance with international IVD medical device quality systems. The successful candidate will have substantial experience in medical device QA, with a focus on design controls and regulatory affairs.

Qualifications

• Minimum experience in medical device Quality Assurance.
• Working knowledge of design controls for regulated products.
• Experience in IVD medical device new product development and design controls.

Responsibilities

• Work on-site projects for New Product Development and Product Lifecycle Management.
• Conduct duties related to design assurance within budget and schedule.
• Collaborate on global regulatory submissions including FDA and IVDR CE certifications.

Skills

Knowledge of design controls

IVD medical device quality systems

Planning and organizing

Collaboration with Regulatory Affairs

Education

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

Job description

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Senior Quality Assurance Officer, Luton, Bedfordshire

Client: Jackson Hogg

Location: Luton, Bedfordshire, United Kingdom

Job Category: Other

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, organise, and conduct duties related to design assurance, ensuring the execution of tasks 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 increasing responsibility in medical device Quality Assurance.

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, which is a distinct advantage.