Quality Manager

Recruiter
Sheffmed
Location
Doncaster
Posted
14 Apr 2018
Closes
14 May 2018
Sector
Healthcare
Contract Type
Permanent
Hours
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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