Senior Quality Assurance Officer

JR United Kingdom; Bath; On-site; GBP 35,000 - 55,000; Full time

Job summary

A leading company in the medical device sector is seeking a Quality Assurance professional for a 12-month maternity cover position. The role involves managing quality assurance for new product development and regulatory compliance, requiring a strong background in IVD medical devices. The candidate will work on site in Newcastle-upon-Tyne, ensuring that projects are completed within budget and timeline while maintaining compliance with international standards.

Qualifications

• Experienced with design controls for medical devices.
• Proven track record in IVD product development and quality assurance.
• Strong knowledge of FDA requirements and ISO standards.

Responsibilities

• Support NPD and PLCM projects to ensure timely delivery.
• Collaborate with Regulatory Affairs for global submissions.
• Plan and execute design assurance tasks.

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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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