Design Assurance Engineer

Kinetica; North East; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading diagnostics company in North East England seeks a Quality Professional to support product development and design control. The role requires strong knowledge of Design Controls for medical devices, as well as extensive experience in quality systems. You will collaborate with teams on regulatory submissions and improve processes to enhance product robustness. This is a full-time, site-based role within a newly formed team.

Qualifications

• Strong knowledge of Design Controls and development practices for medical devices.
• Extensive experience in medical device development and quality systems.
• Expert understanding of standards such as 21 CFR 820 and ISO 13485.

Responsibilities

• Support site projects for new product development.
• Collaborate across sites for Design Control.
• Improve processes to enhance product robustness.

Skills

Design Control knowledge

Medical device development

Quality leadership

Regulatory Affairs collaboration

Education

Bachelor’s degree in a scientific or technical discipline

Job description

Kinetica, Tyne And Wear, England, United Kingdom

Base pay range

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About the Company

We are looking for a quality professional with extensive experience in compliance for product development and design control, to work for a leading diagnostics company. This is a fully site-based role within a newly formed team.

Responsibilities

• Support site projects that drive new product development (NPD) and product lifecycle management (PLCM).
• Provide Design Control leadership and collaborate across LBS and Danaher sites.
• Improve processes to reduce variability and strengthen product robustness.
• Lead functional teams or medium-scale projects as needed.
• Partner with Regulatory Affairs on global submissions, including FDA 510(k), PMA, and IVDR CE documentation.

Requirements

• Strong knowledge of Design Controls and design/development practices for medical device or diagnostic products.
• Extensive experience in medical device development and quality systems.
• Expert understanding of standards such as 21 CFR 820, ISO 13485, ISO 14971, and MDSAP.
• Proven Quality leadership experience.
• Bachelor’s degree in a scientific, or technical discipline.

Seniority level

• Not Applicable

Employment type

• Full-time

Job function

• Quality Assurance and Research

Industries

• Medical Equipment Manufacturing
• Measuring and Control Instrument Manufacturing
• Biotechnology Research

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