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.
Salary: up to £40K
- 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.
- 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).
- 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.