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 ISO13485 certification along with the creation and measurement of key business quality metrics.
Responsibilities
Maintain ISO13485 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
Experience / Qualifications
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