Job Ref: 214009984

Date: 2021-06-18 11:13:55

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SRG partner with a fast-growing Medical Device Maintenance and Supply Company based in High Wycombe.

Reporting the Quality and Regulatory Affairs Manager, your experience in QA will enable you to lead audits, improve processes and deputise for the senior leadership team. Your expertise will enable you to lead the team through their EQMS transition.

Key Responsibilities:

Perform internal audits on ISO 9001:2015 and ISO 13485:2016 compliance at head office and occasionally at hospital sites across England
Report and manage non-conformances (CAPAs, deviations) and perform root cause analysis
Manage, update, create procedures (SOPs) and assist other departments in writing and revising procedures
Contribute to ensuring regulatory compliance
Deputise for the Quality Manager as and when required
Perform supplier audits and evaluations
Deal with customer complaints and customer feedback
Trend, analyse and report data for Management Review Meetings
Be instrumental in the implementation of an Electronic Quality Management System
Provide employee training on the quality management system, ISO standards and MHRA requirements

Experience/Skills

Experience in a Quality Assurance role, within a highly regulated industry: Medical Device, Pharmaceutical, Cosmetics or similar
Qualified Internal Auditor
Knowledge and understanding of ISO 9001:2015 Quality Management System Standard – ISO 13485:2016 desirable
Experience using, or implementing EQMS systems – transition from QMS
CAPA, Root Cause Analysis, SOP writing
Self-motivated, proactive and results driven
Strong problem solving skills, with high levels of attention to detail
Desire to learn, progress and provide innovation
Full UK Driving License Benefits:

Work closely with the senior leadership team
Expert training and development plansPrivate Health Insurance
Death in Service Scheme
Pension Scheme
Onsite parking
25 days holiday + bank holidays

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