Find YOUR better job
Minimum Salary
£0k
 
 

Quality Assurance Engineer

10059
to £40,000

Job Description

Description:  To assist the QA/RA Manager in maintaining and improving the Quality Management System. 

Reporting to:  QA/RA Manager 

Key contacts in company:  QA/RA Manager, Quality Control Inspector, R&D Department, Manufacturing Director, Manufacturing Team Leader, Customer Services Department, Chief Executive, Chief Scientific Officer. 

Key contacts outside of Company:  Vendors, Notified Bodies, Sub-contract Regulatory Consultants, and Engineering Test Houses. 

Location:  Chichester 

Salary: up to £40K 

Benefits: 

  • 27 days holiday plus 8 days public holidays
  • Holiday purchase scheme allowing purchase of 5 days additional holiday via salary sacrifice
  • Pension 4% matched by employee and employer
  • PHI Scheme pays 75% of salary after 6 months long term absence – following probationary period completion

Primary role: Assist the QA/RA Manager in maintaining and improving the QA/RA functions. 

Key Tasks: 

  • Maintenance and improvement of the QMS/QSR in accordance with BS EN ISO 13485 & 21 CFR Part 820. 
  • Streamline the current QMS system to reflect current processes. 
  • Experience compiling and maintaining device technical files and 510K. (RA) 
  • Processing of change orders through to their completion. 
  • Assist in the writing and amendment of standard operating procedures. 
  • Maintaining and introducing new modules to the electronic document management system (Entropy). 
  • Raise and follow up of corrective and preventative action plans. 
  • Assisting and conducting internal and supplier Quality System Audits and follow up actions as required. 
  • Assisting the Quality/Regulatory Department in any Notified Body, Competent Authority and regulatory audits. (RA) 
  • Participate in risk assessments in accordance with BS EN ISO 14971 through the use of FMEA analysis. 
  • Assist and support the R&D department in new projects and transfer to manufacturing. 
  • Assist and support the manufacturing department in all quality related issues. 
  • Environmental trend analysis of cleanroom and product bioburden data. 
  • Facilitate the implementation of Unique Device Identification (UDI).

Requirements:

  • Degree or equivalent experience in an appropriate academic discipline.
  • Minimum 3 years Quality Assurance Class IIa/IIb & III (preferably active/software Medical Device experience.
  • BS EN ISO 13485, 21 CFR Part 820 essential.
  • MDD 93/42/EEC, BS EN ISO 14971, EN 62304, IEC 60601, ISO 11135, ISO 14644 desirable.
  • Experience of auditing desirable.