Senior Quality Assurance Officer

JR United Kingdom; Sunderland; On-site; GBP 35,000 - 50,000; Full time

Job summary

A leading company in Quality Assurance is seeking a Senior Quality Assurance Officer to join their team in Sunderland, UK. This temporary 12-month position focuses on supporting new product development and ensuring compliance with international quality standards. The ideal candidate will possess extensive knowledge in IVD medical device quality systems and a strong background in regulatory affairs, advancing their career in a vital role within the industry.

Qualifications

• Working knowledge of design controls for regulated products.
• Experience in IVD medical device new product development.
• Knowledge of international quality systems (21 CFR 820, ISO 13485).

Responsibilities

• Conduct duties related to design assurance ensuring budget and schedule compliance.
• Support global regulatory submissions including FDA and CE certifications.
• Plan and organize site projects for New Product Development.

Skills

Design controls for regulated products

IVD medical device new product development

International IVD medical device quality systems

Education

Bachelor’s degree in science, medical or technical field

Job description

Social network you want to login/join with:

Senior Quality Assurance Officer, sunderland, tyne and wear

col-narrow-left

Client:

Jackson Hogg

Location:

sunderland, tyne and wear, United Kingdom

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Views:

5

Posted:

06.06.2025

Expiry Date:

21.07.2025

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