Senior Quality Assurance Officer

JR United Kingdom; Watford; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading company in the medical device sector seeks a Senior Quality Assurance Officer in Watford for a 12-month temporary position covering maternity leave. The role involves overseeing design assurance tasks, working on regulatory submissions, and collaborating with various teams to support product development initiatives. Applicants should possess a strong knowledge background in IVD processes and quality systems, as well as relevant educational qualifications.

Qualifications

• Experience increasing in responsibility within medical device Quality Assurance.

Responsibilities

• Plan, organize, and conduct duties related to design assurance.
• Collaborate closely with Regulatory Affairs on deliverables for global regulatory submissions.

Skills

Knowledge of design controls for regulated products

Experience in IVD medical device new product development

Extensive knowledge of international IVD medical device quality systems

Education

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

Job description

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Senior Quality Assurance Officer, Watford, Hertfordshire

Client:

Jackson Hogg

Location:

Watford, Hertfordshire, 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 supporting the progression of commercial/strategic opportunities for New Product Development (NPD) or Product Lifecycle Management (PLCM).
• Plan, organize, and conduct duties related to design assurance, ensuring tasks are completed within budget and on 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:

• 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 responsibility within medical device Quality Assurance.

Preferred additional experience includes:

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