Quality Engineer; Medical Devices

GM Instruments are looking to recruit a Quality Engineer to join our business at a time of exciting growth for the company.

The Position:
Within the role you will be responsible for the management and implementation of the Quality Management System and ISO
13485 certification along with the creation and measurement of key business quality metrics.

• Maintain ISO
  13485 Quality Management Systems for GM Instruments and EMS Physio.
• Review and update Quality Manuals, procedures, forms, templates, and Work Instructions
• Creation of annual audit plan, perform internal audits, generation of audit reports
• Generation, closure, and management of CAPA’s
• Execution of Quality Calendar and updates to KPI dashboard
• Verify Technical Documentation compliance with MDD 93/42/EEC & MDR 2017/745
• Perform Post Market Surveillance activities including PMCF & PSUR
• Confirm applicable National, European, and international standards, directives and regulations are at current revision and integrated in both QMS
• Perform Risk Management activities as defined in BS EN ISO 14971:2019
• Support QMS and Technical Documentation transition from MDD to MDR
• Root Cause Corrective Action (RCCA) on field returns and customer complaints
• Support UKCA application and registration with UK Approved Body

• Minimum 1 years’ experience working as a Quality Engineer
• Experience in medical device manufacture, or the Pharmaceutical industry
• Educated to degree level, or equivalent, in a Science or Engineering based discipline
• Familiar with Medical Device Directive 93/42/EEC and Medical Device Regulation 2017/745
• CAPA and Non-Conformance Reporting experience
• Proficient with MS office suite of product