• Understand and review Validation documentation, Change Requests, Design and Process FMEA’s, Test Summaries, Software Validation, Microbiological assessments and Critical System Work Orders.
• Provide Quality Engineering support to the Research and Development and Sustaining Engineering departments up to and including transfer to Production, understanding Design Assurance activities, reviewing associated documents including Design Verification/Design Validation, Design and Process FMEA, Process Validation and Test Summaries.
• Support the Supplier Appraisal and Approval processes.
• Liaise with Production and Quality Control by providing Quality Engineering support to Incoming Quality Control, In-Process and Final Quality Control.
• Provide input and support to the Corrective and Preventive Action program (CAPAs) and the Non-Conforming Product Process.
• Support of the Internal Audit, Supplier Audit and Regulatory Audit Programmes
• Conducting, documenting and reviewing complaint investigations.
• Risk assessment of customer complaints, Non-conformance and CAPA
• Initiate, manage and execute projects for continuous improvement within the department.
Qualifications / Requirements:
• Third Level qualification in Science, Engineering or a relevant technical discipline.
• Qualification in Quality/Validation/Statistics/ Risk would be a distinct advantage.
• Proven knowledge and experience (ideally minimum 4 years) of working with ISO13485, ISO14971, the Medical Device Directive, EU Medical Device Regulation 2017/745 and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry.
• Proven knowledge and experience of all aspects of Validation including Design, Process Validation and Software Validation.
• Good working knowledge of statistics
• Strong interpersonal skill with the ability to communicate effectively at all organisational levels.