Medical Device QA Lead — QMS & ISO 13485

Newton Colmore Consulting; Cambridge; On-site; GBP 30,000 - 50,000; Full time

Job summary

An established industry player in the Medical Devices sector is seeking a Quality Assurance Specialist in Cambridge. This role offers an exciting opportunity to develop and manage a Quality Management System (QMS) under ISO 13485 standards. You will be responsible for creating technical files for various Medical Devices, collaborating with experts, and leading Quality Assurance efforts. Ideal for candidates seeking to advance their careers in Quality Assurance, this position encourages growth and offers the potential for hybrid working arrangements in the future. If you are ready to take on more responsibility and make a significant impact, this opportunity is perfect for you.

Qualifications

• Degree in a related field leading to Quality Assurance roles.
• Experience with ISO 9001 or QMS is beneficial.

Responsibilities

• Develop and manage the QMS system for ISO 13485 standards.
• Create technical files for various Medical Devices lines.
• Collaborate with Medical Devices experts on Quality Assurance.

Skills

ISO 13485

Quality Assurance

Regulatory Affairs

Quality Engineering

ISO 9001

Education

Degree in Quality Assurance or related field

Job description

An established industry player in the Medical Devices sector is seeking a Quality Assurance Specialist in Cambridge. This role offers an exciting opportunity to develop and manage a Quality Management System (QMS) under ISO 13485 standards. You will be responsible for creating technical files for various Medical Devices, collaborating with experts, and leading Quality Assurance efforts. Ideal for candidates seeking to advance their careers in Quality Assurance, this position encourages growth and offers the potential for hybrid working arrangements in the future. If you are ready to take on more responsibility and make a significant impact, this opportunity is perfect for you.