Quality Assurance Specialist - Cambridge

Newton Colmore Consulting; Cambridge; On-site; GBP 30,000 - 45,000; Full time

Job summary

A growing Medical Devices company in Cambridge is seeking a Quality Assurance Specialist to develop their QMS system for ISO 13485 standards. This role offers an excellent opportunity for candidates early in their career or those looking to transition into the Medical Devices sector, with support from experienced professionals.

Qualifications

• Experience in ISO 9001 or QMS is beneficial.
• Understanding of Regulatory Affairs is advantageous.
• Experience in Medical Devices Quality Assurance is beneficial but not essential.

Responsibilities

• Create and manage technical files for Class I, IIa, and IIb Medical Devices.
• Collaborate with Medical Devices experts while focusing on Quality Assurance duties.
• Assist in the development of the QMS system for ISO 13485 standards.

Skills

Quality Assurance

Regulatory Affairs

QMS

Education

Degree in Quality Assurance, Quality Engineering, or Design Assurance

Job description

Quality Assurance Specialist - Cambridge

A growing Medical Devices company based in Cambridge is currently looking for a new Quality Assurance Specialist to assist in the development of the QMS system for ISO 13485 standards. They are open to candidates from alternative sectors, allowing for ISO 13485 standards training.

You will be responsible for creating and managing technical files for several Medical Devices lines, including Class I, Class IIa, and Class IIb Medical Devices. You will collaborate with Medical Devices experts but will be the sole person focusing on Quality Assurance duties. However, you will receive support from the parent company's Quality Assurance Manager.

We are open to candidates with a couple of years of experience in ISO 9001 or QMS, as well as those with more extensive experience.

This is an excellent opportunity for someone early in their career seeking more responsibility in developing a QMS system or for those looking to enter the Medical Devices sector under ISO 13485 standards. Due to active work in setting up the QMS, you will need to be in the office daily, with potential for hybrid working over time.

Candidates should hold a degree related to Quality Assurance, Quality Engineering, or Design Assurance.

Having a good understanding of Regulatory Affairs would be highly advantageous.

Part of your role will involve working alongside manufacturing teams. Experience in Medical Devices Quality Assurance from a Quality Engineering background is beneficial but not essential.

Interested candidates are encouraged to apply promptly to avoid missing out.

For more information, please contact Andrew Welsh, Director of Medical Devices Recruitment at Newton Colmore Consulting, at [phone], or submit an application for our team to contact you.