Senior Quality Assurance Officer

JR United Kingdom; Swindon; On-site; GBP 45,000 - 60,000; Full time

Job summary

A leading company seeks a Senior Quality Assurance Officer for a temporary 12-month role in Swindon. This position involves overseeing design assurance for IVD medical devices and complying with regulatory submissions, including FDA certifications. Ideal candidates will have a Bachelor’s degree in a relevant field and significant experience in quality assurance within the medical device sector.

Qualifications

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

Responsibilities

• Support site projects for New Product Development (NPD).
• Plan and conduct design assurance tasks.
• Collaborate with Regulatory Affairs on submissions.

Skills

Design controls

Quality Assurance

Regulatory Affairs

Education

Bachelor’s degree in science, medical or technical field

Job description

Social network you want to login/join with:

Senior Quality Assurance Officer, swindon, wiltshire

col-narrow-left

Client:

Jackson Hogg

Location:

swindon, wiltshire, United Kingdom

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Views:

2

Posted:

04.06.2025

Expiry Date:

19.07.2025

col-wide

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