Senior Quality Assurance Officer

Jackson Hogg; Newcastle upon Tyne; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading company in the medical device industry offers a temporary 12-month position for a Quality Assurance professional. In this role, you will deliver crucial support for product development and regulatory compliance, requiring a strong educational background and relevant experience in IVD devices.

Qualifications

• Strong understanding of design controls related to regulated products.
• Experience with increasing responsibility in medical device Quality Assurance.

Responsibilities

• Support projects for new product development and lifecycle management.
• Plan and conduct design assurance duties ensuring budget and schedule adherence.
• Collaborate with Regulatory Affairs for global submissions.

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

Direct message the job poster from Jackson Hogg

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
• Experience with the MDSAP Programme

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

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