Senior Quality Assurance Officer

JR United Kingdom; City of Edinburgh; 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 12-month temporary position in Edinburgh. The successful candidate will handle design assurance, regulatory submissions, and contribute to new product development in a dynamic environment, ensuring compliance with quality standards.

Qualifications

• Working knowledge of design controls for regulated products.
• Extensive knowledge of international IVD medical device quality systems.
• Experience of increasing responsibility in medical device Quality Assurance.

Responsibilities

• Plan and conduct design assurance duties ensuring budget and schedule compliance.
• Collaborate on global regulatory submissions, including FDA and CE certifications.
• Support new product development and product lifecycle management.

Skills

Knowledge of design controls

Experience in IVD medical device development

Knowledge of quality systems

Education

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

Job description

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Senior Quality Assurance Officer, Edinburgh

Client:

Jackson Hogg

Location:

Edinburgh, 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 task execution within budget and schedule.
• Collaborate 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.