Senior Quality Assurance Officer

JR United Kingdom; Woking; On-site; GBP 40,000 - 65,000; Full time

Job summary

A leading company in the medical device sector is seeking a Senior Quality Assurance Officer for a temporary position in Woking. This role involves ensuring compliance with quality systems and supporting new product development efforts. The successful candidate will have a strong background in IVD medical devices and regulatory requirements, contributing to critical quality assurance activities within a fast-paced environment.

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

• Plan, organize, and conduct duties related to design assurance.
• Work closely with Regulatory Affairs on global regulatory submissions.
• Support new product development opportunities.

Skills

Design controls for regulated products

IVD medical device quality systems

Regulatory Affairs

Education

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

Job description

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Senior Quality Assurance Officer, Woking

Client:

Jackson Hogg

Location:

Woking, United Kingdom

Job Category:

Other

EU work permit required:

Yes

Job Views:

3

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 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.