Technician Quality Control
h3Job Description /h3 h3Key Responsibility /h3 ul liReview documentation for SOP, Test Instruction and Calibration Procedure. /li liFinal review release of Medical Device History Records (DHRs). /li liIdentify and initiate NCR internal and external (Supplier). /li liOwn and drive CAPA to completion. /li liAssist with incoming inspection, in process inspection, returns and continuous improvement initiatives. /li liSupport packaging control and change. /li liPerform visual, dimensional, and functional inspections on in-process components and finished product lots. /li liInvestigate and valuate customer complaints. /li liMonitor and maintain the calibration and maintenance schedules for laboratory instruments and production measurement gauges. /li liExpertise of technical instrument for chemical analysis included result interpretation. /li liInitiate and support change control ECR/ECO. /li liParticipate in cross-functional QA meetings and provide quality support. /li liAssist the Quality Assurance during internal audits and external inspections by Notified Bodies or regulatory authorities (e.g., BSI, FDA etc). /li liPrepare deck for QA Operations slides, including trending and escalation. /li /ul h3Job Requirements /h3 h3Technical Skills /h3 ul lipbRegulatory Knowledge: /b Understanding of bISO 13485 /b (Medical Devices – Quality Management Systems) and bMDR 2017/745 /b regulations. /p /li lipbMeasurement Tools Instruments for chemical analysis laboratories: /b Proficiency with calipers, micrometers,
optical comparators, microscopes, HPLC, GC, pH-meter, IR, Spectrometer, etc… /p /li lipbSoftware Systems: /b Experience using ERP software (e.g., Oracle) /p /li lipbAutomation/AI: /b Experience in test Automation and AI-driven /p /li lipbProblem Solving: /b Perform root cause investigation of issue and propose potential CA /p /li /ul h3Soft Skills /h3 ul libAttention to Detail: /b Critical for spotting minor deviations that could impact patient safety or device performance. /li libAnalytical Problem Solving: /b Ability to evaluate technical data to resolve manufacturing anomalies. /li libCross-Functional Communication: /b Capability to effectively collaborate with Production, RD, and Procurement departments regarding quality issues. /li libPrioritization/Organizational: /b Good prioritizing, organizational, interpersonal, communication and analytical skills /li /ul h3Typical Requirements /h3 ul libEducation: /b Bachelor’s degree in bBiomedical Engineering /b , Materials Science, Biotechnology, Chemistry, or a related technical discipline. /li libExperience: /b 1–3 years of proven experience in a quality assurance/control role within a regulated environment (Medical Devices or Pharmaceuticals). /li libLanguages: /b Professional proficiency in English (both written and spoken) for reviewing standards, files, and supplier documentation. /li /ul h3Operating Company /h3 pKerr /p #J-18808-Ljbffr
optical comparators, microscopes, HPLC, GC, pH-meter, IR, Spectrometer, etc… /p /li lipbSoftware Systems: /b Experience using ERP software (e.g., Oracle) /p /li lipbAutomation/AI: /b Experience in test Automation and AI-driven /p /li lipbProblem Solving: /b Perform root cause investigation of issue and propose potential CA /p /li /ul h3Soft Skills /h3 ul libAttention to Detail: /b Critical for spotting minor deviations that could impact patient safety or device performance. /li libAnalytical Problem Solving: /b Ability to evaluate technical data to resolve manufacturing anomalies. /li libCross-Functional Communication: /b Capability to effectively collaborate with Production, RD, and Procurement departments regarding quality issues. /li libPrioritization/Organizational: /b Good prioritizing, organizational, interpersonal, communication and analytical skills /li /ul h3Typical Requirements /h3 ul libEducation: /b Bachelor’s degree in bBiomedical Engineering /b , Materials Science, Biotechnology, Chemistry, or a related technical discipline. /li libExperience: /b 1–3 years of proven experience in a quality assurance/control role within a regulated environment (Medical Devices or Pharmaceuticals). /li libLanguages: /b Professional proficiency in English (both written and spoken) for reviewing standards, files, and supplier documentation. /li /ul h3Operating Company /h3 pKerr /p #J-18808-Ljbffr