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 ***** (Medical Devices – Quality Management Systems) and MDR ******** 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 ****.
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-*****-Ljbffr

📌 Technician Quality Control (Scafa)
🏢 Envista
📍 Scafa