Partner with R&D, Marketing, Regulatory Affairs, and Operations to support activities in product and process design such as design verification, design validation, design reviews, design transfer, and all other aspects of a design history file.
Create and maintain risk files consisting of but not limited to risk management plans, hazard and risk analyses, failure mode and effects analyses and risk management reports to assess the risks associated with a product.
Analyze post-market surveillance data periodically throughout a product’s lifecycle to feed back into it’s risk file in order to reflect it's current risk profile. Support Clinical and Medical Writers in the analysis of available clinical data, as required.
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Test, diagnose, rework, and verify PSU sub-component and final electronic products of moderate to high complexity as prescribed by drawings, electrical schematics, and/or procedures.
Strong ability to Test and diagnose units with minimal direction.
Record failure data and test issues in databases as required. Work with Test engineers to document product repair changes. Evaluate results and recommend corrective action when required.
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Lead the quality team and be site representative for ISO9001, ISO13485 and ISO14001 for XP MY plant
Further develop monthly KPI’s on the health of the business and report to the management team with continuous improvement plans.
Provide leadership of the quality organization to help drive a proactive approach with improvements within design, manufacturing, suppliers and customers.
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Fill in and maintain all Standard Operating Procedure (SOP) and Prerequisite Programme (PRP) manuals and their supporting forms and logs (e.g. temperature logs, cleaning and sanitation records, pest control checklists, incoming goods inspection, CCP monitoring records, equipment calibration records, training records).
Keep all food safety documentation organised, complete and audit-ready at all times, without gaps or missing paperwork.
Act as the day-to-day point of contact with our external HACCP/food safety consultant: implement the documentation system the consultant designs, flag any records that don't fit real factory conditions, and keep the paper trail current between consultant visits.
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