Quality Specialist - Medical Devices

Search Consultancy

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Job ID :


Company Type :

Staffing Firms

Industry :

Science and Research

Education Level :

Bsc,Master of Science,Other

Address 1 :

United Kingdom,--Leeds,Leeds,

Key Skills :

quality, assurance, medical, device, devices, pharmaceutical, pharma, engineer, engineering, regulat

Salary :

£30000.00 - £35000.00 per annum + pension and additional benefits

Date Posted :

12 Jan, 2018

Company Name :

Search Consultancy

Location1 :


Job Category :

Quality Assurance Jobs

Experience :


Job Type:


Travel Amount:



Quality Specialist / Design Quality Engineer

Search Scientific is currently recruiting a Quality Specialist for an established manufacturer of innovative medical devices based in Leeds.

The Quality Specialist will be responsible for materials and overall product quality throughout the whole development lifecycle for a range of medical devices, ensuring regulatory requirements are met.

Duties and Responsibilities Key Duties

* Collaborate with the in-house design team and external suppliers/consultancies
* Define and take the lead on all quality aspects of multiple projects
* Perform risk analysis' and create risk documentation such as FMEA
* Work with project teams to identify and carry out design and process validations (IQ/OQ/PQ)
* Advise the design team on relevant standards and regulatory requirements
* Review existing Design History Files/Technical Files to identify testing requirements to meet standards
* Identify and plan testing strategies for various quality related requirements
* Write technical justifications and validation reports
* Create and maintain high quality clinical evaluations

Required Skills, Experience and Education Skills/Experience

* Knowledge/understanding of FDA regulations (including 21CFR 820), EU Medical Device Directives and Canadian Medical Device Regulations required.
* Knowledge of the requirements for international quality systems, including ISO 13485:2012, 9001:2008 required.
* Knowledge of standards relating to cleaning and sterilisation of medical devices.
* Experience in the manufacture and design of Class IIa and IIb sterilised Medical Devices
* 2 years plus experience in a similar role within the Medical Devices industry
* Minimum HND/Bachelor's Degree required, preferably in a STEM subject.

Desirable Skills/Education

* Lead auditor in 9001:2008/13485:2012

Salary: £30000 - £35000 + benefits (negotiable on experience).

Location: Leeds (North)

For more information and to apply, please clicks apply or submit your CV to Stephen Davis: Stephen.davis@search.co.uk

Search is an equal opportunities recruiter and we welcome applications from all suitably skilled or qualified applicants, regardless of their race, sex, disability, religion/beliefs, sexual orientation or age.

Company Name:

Search Consultancy


Campbell House,215 West Campbell Street


Staffing Firms


United Kingdom






100 - 499





Phone No. :


For more information,visit www.search.co.uk.

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