Quality Manager

The SmartList
£30,000 - £39,999
12 Apr 2018
21 Apr 2018
Contract Type
Full Time
LOCATION: Sheffield (S9), South Yorkshire

JOB TITLE: Quality Manager-Part time (20 hours/week)

SALARY & BENEFITS: Circa £30,000 p.a. (After 6 months' employment, we also offer a health cash plan, private medical insurance and life insurance)

WORKING HOURS: To be agreed

THE COMPANY: Quality Manager - Sheffield (S9), South Yorkshire
An exciting opportunity has arisen for a Quality Manager with my client, a medical device manufacturer based in Sheffield, South Yorkshire. They provide technology devices and consumables for healthcare professionals
RESPONSIBILITIES: Quality Manager -Full time - Sheffield (S9), South Yorkshire
Quality Manager required to handle all regulatory and technical aspects covering Class 1, Class 1 sterile and Class IIa products. The company also has a Class 7 cleanroom which would require monitoring and adheres to ISO 13485:2016

Key Experience/ Characteristics preferred for the roles: - Quality Manager Sheffield (S9), South Yorkshire
Maintaining Quality Manual and Product Technical Files
Internal Audits and external Notified Body Audits
Preparation of clinical evaluation reports and risk management reports for all products.
Validation and monitoring of both EtO and Gamma sterilisation
Biocompatibility of products, including defining testing strategies and preparing safety reviews.
Preparation of regulatory submissions
Managing a Class 7 Cleanroom

The Candidate: Quality Manager - Sheffield (S9), South Yorkshire

The ideal candidate will have 3-5 years' experience in a Quality/ auditing role, and have relevant qualifications
Key Criteria's: Quality Manager - Sheffield (S9), South Yorkshire
Previous experience in a similar Quality/ Auditing role essential
Relevant qualifications
Relevant experience in the medical device industry highly advantageous

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