Senior Quality Assurance Officer

JR United Kingdom; Stoke-on-Trent; On-site; GBP 35,000 - 55,000; 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 in Stoke-on-Trent. This role involves ensuring compliance and quality assurance for design projects within their Quality Assurance and Regulatory Compliance Department, while collaborating with Regulatory Affairs on international submissions. Ideal candidates will have a strong background in IVD medical devices and design controls, along with a relevant Bachelor's degree.

Qualifications

• Working knowledge of design controls for regulated products.
• Experience in IVD medical device new product development.
• Extensive knowledge of ISO 13485 standards.

Responsibilities

• Plan, organise, and conduct duties related to design assurance.
• Support global regulatory submissions including FDA and CE certifications.
• Work on-site projects for product strategy and lifecycle management.

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, Stoke-on-Trent

Client: Jackson Hogg

Location: Stoke-on-Trent, 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 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 of 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.