Quality Engineer

Job title : Quality Engineer
Location : Cambridge
Job type : Permanent
Salary : Competitive + private healthcare, bonus
Contact name : Aisling Hamill
Contact email : aisling.hamill@seclifesciences.com

A pioneering medical device company based in Cambridge are looking for a Quality Engineer.

Our client is a fresh and well-funded diagnostics start-up. The successful candidate will be involved in helping bring their product to market, ensuring quality requirements are met from concept through design and development to manufacture.

What you will be doing:

Product risk management activities according to ISO 14971 * Provide oversight of hazard analyses, FMEAs, FTAs

Prepare and manage Risk Management Plans and Reports as well as hazard traceability matrices

Act as Quality representative at Design Authority and Design Review meetings

Maintain and manage the Design History File and Technical Design Dossier

Ensure technical and design changes are suitably documented and regulatory authorities are notified where necessary

Maintain and manage regulatory activities throughout product design and development activities

A little about you:

You have previously worked in the field of medical devices and its relevant regulatory frameworks, preferably in design and development of IVDs

You have an engineering degree or equivalent experience in an engineering role

You have an understanding of key medical device standards i.e., ISO13845, 14971, 62304, QSR and 60601

You have previously worked as part of a Design Review authority as part of a Design Authority

You can apply core quality tools and methodologies such as 8D and DMAIC

We would love to hear from you if:

You have experience bringing a medical device to the market in the USA and in other territories

You have experience in cGMP, QC and manufacturing line validation * You are a trained ISO 13485 Internal Auditor

You have previous experience with risk and design control modules of quality and eQMS software

What's in it for you?

Our client is an employee-owned business

Employer pension-contribution of 12% of pensionable salary

Bonuses are profit-related

Private medical insurance

Life insurance

25 days' annual holiday (+ bank holidays)

Discounts and memberships to local sports facilities and the theatre

Cycle to work scheme

A relocation package is available where applicable

If you would be interested in a confidential discussion about this or other roles you can contact Aisling Hamill at aisling.hamill@seclifesciences.com or on +443303353017.