Senior Quality Assurance Officer

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

Job summary

A leading company in the medical device industry is seeking a Senior Quality Assurance Officer for a temporary 12-month role based in Maidstone. This position focuses on design assurance, global regulatory submissions, and maintaining quality systems for IVD medical devices. The ideal candidate will bring extensive experience in quality assurance and regulatory affairs, ensuring compliance with industry standards.

Qualifications

• Experience with medical device quality assurance with increasing responsibility.
• Knowledge of international IVD quality standards like ISO 13485 and 21 CFR 820.

Responsibilities

• Manage design assurance tasks to ensure timely project delivery.
• Collaborate with Regulatory Affairs for global submissions including FDA.
• Support NPD and PLCM initiatives.

Skills

Design controls knowledge

IVD medical device development

Quality systems knowledge

Education

Bachelor’s degree in science, medical or technical field

Job description

Social network you want to login/join with:

Senior Quality Assurance Officer, maidstone

col-narrow-left

Client:

Jackson Hogg

Location:

maidstone, United Kingdom

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Views:

2

Posted:

04.06.2025

Expiry Date:

19.07.2025

col-wide

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