Quality Assurance Engineer

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.