Senior Quality Assurance Officer

JR United Kingdom; Crawley; On-site; GBP 40,000 - 55,000; Full time

Job summary

A reputable organization is looking for a Senior Quality Assurance Officer to manage design assurance in Crawley. This role entails collaborating with various departments to ensure regulatory compliance in new product development within a dynamic environment. Ideal candidates will have strong knowledge of IVD regulations and quality systems, along with substantial experience in medical device quality assurance.

Qualifications

• Knowledge of design controls for regulated products.
• Experience in IVD medical device development.
• Extensive knowledge of medical device quality systems.

Responsibilities

• Support projects for New Product Development.
• Plan and execute design assurance tasks.
• Collaborate on regulatory submissions.

Skills

Knowledge of design controls

Experience in IVD medical device development

Knowledge of international quality systems

Education

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

Job description

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Senior Quality Assurance Officer, Crawley, West Sussex

Client: Jackson Hogg

Location: Crawley, West Sussex, 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. The role will be on-site.

In this role, you will have the opportunity to:

• Support on-site projects to advance commercial/strategic opportunities for New Product Development (NPD) or Product Lifecycle Management (PLCM).
• Plan, organise, and execute design assurance tasks, ensuring timely delivery within budget.
• Collaborate closely with Regulatory Affairs on global regulatory submissions, including FDA 510(k)s, PMAs, and IVDR CE certifications.

The essential requirements of the job include:

• 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 21 CFR 820 and ISO 13485.
• Bachelor’s degree in science, medical, or technical field, with experience increasing in medical device Quality Assurance.

Preferred additional experience:

• Experience with higher classification IVD/Medical devices and companion diagnostics.
• IVD medical device regulatory affairs experience is a plus.