Senior Quality Assurance Officer

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

Job summary

A leading company is seeking a Senior Quality Assurance Officer to support design assurance and regulatory compliance for medical devices on-site in Ipswich. This temporary position for maternity cover entails involvement in new product development and ensuring compliance with quality systems. Candidates must have a bachelor's degree in a technical field and relevant experience in quality assurance and regulatory processes.

Qualifications

• Experience with increasing responsibility in medical device Quality Assurance.
• Extensive knowledge of international IVD medical device quality systems.

Responsibilities

• Plan, organise and conduct duties related to design assurance.
• Work closely with Regulatory Affairs for global regulatory submissions.

Skills

Working knowledge of design controls

Experience in IVD medical device development

Knowledge of ISO 13485

Education

Bachelor’s degree in science, medical or technical field

Job description

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Senior Quality Assurance Officer, ipswich

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Client:

Jackson Hogg

Location:

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