Senior Quality Assurance Officer

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

Job summary

A leading company in the medical device sector seeks a Senior Quality Assurance Officer for a temporary 12-month maternity cover role in Southampton. The successful candidate will focus on design assurance, regulatory compliance, and support the new product development process, ensuring alignment with quality standards. Ideal candidates will have a strong background in IVD medical device quality systems and a relevant degree.

Qualifications

• Experience with increasing responsibility in medical device Quality Assurance.
• Knowledge of 21 CFR 820 and ISO 13485.

Responsibilities

• Conduct duties related to design assurance and task execution.
• Work closely with Regulatory Affairs on global regulatory submissions.
• Plan and organize projects for New Product Development.

Skills

Working 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, southampton

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Client:

Jackson Hogg

Location:

southampton, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

2

Posted:

04.06.2025

Expiry Date:

19.07.2025

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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