Senior Quality Assurance Officer

JR United Kingdom; Bolton; On-site; GBP 35,000 - 50,000; Full time

Job summary

A prominent company in the medical sector is searching for a Senior Quality Assurance Officer to join their team in Bolton for a temporary maternity cover position. The ideal candidate will have extensive experience in IVD medical device quality systems and a solid educational background in a relevant field. This role involves critical responsibilities in regulating product design controls and supporting regulatory submissions globally.

Qualifications

• Working knowledge of design controls for regulated products essential.
• Experience with IVD medical device development required.
• Familiarity with FDA 510(k) and CE certifications beneficial.

Responsibilities

• Support projects for New Product Development and Product Lifecycle Management.
• Conduct design assurance duties ensuring budget and schedule adherence.
• Collaborate with Regulatory Affairs on global submissions.

Skills

Design controls for regulated products

IVD medical device new product development

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, bolton, greater manchester

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Client:

Jackson Hogg

Location:

bolton, greater manchester, 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