Technician Quality Control
h3Job Description /h3ulliKey Responsibility: Review documentation for SOP, Test Instruction and Calibration Procedure. /liliFinal review release of Medical Device History Records (DHRs). /liliIdentify and initiate NCR internal and external (Supplier). /liliOwn and drive CAPA to completion. /liliAssist with incoming inspection, in process inspection, returns and continuous improvement initiatives. /liliSupport packaging control and change. /liliPerform visual, dimensional, and functional inspections on in-process components and finished product lots. /liliInvestigate and valuate customer complaints. /liliMonitor and maintain the calibration and maintenance schedules for laboratory instruments and production measurement gauges. /liliExpertise of technical instrument for chemical analysis included result interpretation. /liliInitiate and support change control ECR/ECO. /liliParticipate in cross-functional QA meetings and provide quality support. /liliAssist the Quality Assurance during internal audits and external inspections by Notified Bodies or regulatory authorities (e.g., BSI, FDA etc). /liliPrepare deck for QA Operations slides, including trending and escalation. /li /ulh3Job Requirements /h3ulliTechnical Skills Regulatory Knowledge: Understanding of ISO 13485 (Medical Devices – Quality Management Systems) and MDR 2017/745 regulations. /liliMeasurement Tools Instruments for chemical analysis laboratories: Proficiency with calipers, micrometers, optical comparators, microscopes, HPLC, GC, pH-meter, IR, Spectrometer, etc… /liliSoftware Systems: Experience using ERP software (e.g., Oracle) /liliAutomation/AI: Experience in test Automation and AI-driven Problem Solving: Perform root cause investigation of issue and propose potential CA /liliSoft Skills Attention to Detail: Critical for spotting minor deviations that could impact patient safety or device performance. /liliAnalytical Problem Solving: Ability to evaluate technical data to resolve manufacturing anomalies.
/liliCross-Functional Communication: Capability to effectively collaborate with Production, RD, and Procurement departments regarding quality issues. /liliPrioritization/Organizational: Good prioritizing, organizational, interpersonal, communication and analytical skills /liliTypical Requirements Education: Bachelor’s degree in Biomedical Engineering, Materials Science, Biotechnology, Chemistry, or a related technical discipline. /liliExperience: 1–3 years of proven experience in a quality assurance/control role within a regulated environment (Medical Devices or Pharmaceuticals). /liliLanguages: Professional proficiency in English (both written and spoken) for reviewing standards, files, and supplier documentation. /li /ulpEnvista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. /ppEnvista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. /ppOur comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. /ppEnvista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care. /ppEnvista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. /ppEnvista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. /ppFor more information, please visit /p #J-18808-Ljbffr
/liliCross-Functional Communication: Capability to effectively collaborate with Production, RD, and Procurement departments regarding quality issues. /liliPrioritization/Organizational: Good prioritizing, organizational, interpersonal, communication and analytical skills /liliTypical Requirements Education: Bachelor’s degree in Biomedical Engineering, Materials Science, Biotechnology, Chemistry, or a related technical discipline. /liliExperience: 1–3 years of proven experience in a quality assurance/control role within a regulated environment (Medical Devices or Pharmaceuticals). /liliLanguages: Professional proficiency in English (both written and spoken) for reviewing standards, files, and supplier documentation. /li /ulpEnvista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. /ppEnvista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. /ppOur comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. /ppEnvista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care. /ppEnvista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. /ppEnvista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. /ppFor more information, please visit /p #J-18808-Ljbffr