Technician Quality Control
Key Responsibility
* Review documentation for SOP, Test Instruction and Calibration Procedure.
* Final review & release of Medical Device History Records (DHRs).
* Identify and initiate NCR internal and external (Supplier).
* Own and drive CAPA to completion.
* Assist with incoming inspection, in process inspection, returns & and continuous improvement initiatives.
* Support packaging control and change.
* Perform visual, dimensional, and functional inspections on in-process components and finished product lots.
* Investigate and valuate customer complaints.
* Monitor and maintain the calibration and maintenance schedules for laboratory instruments and production measurement gauges.
* Expertise of technical instrument for chemical analysis included result interpretation.
* Initiate and support change control ECR/ECO.
* Participate in cross-functional QA meetings and provide quality support.
* Assist the Quality Assurance during internal audits and external inspections by Notified Bodies or regulatory authorities (e.g., BSI, FDA etc).
* Prepare deck for QA Operations slides, including trending and escalation. Job RequirementsTechnical Skills
* Regulatory Knowledge: Understanding of ISO 13485 (Medical Devices – Quality Management Systems) and MDR 2017/745 regulations.
* Measurement Tools & Instruments for chemical analysis laboratories: Proficiency with calipers,
micrometers, optical comparators, microscopes, HPLC, GC, pH-meter, IR, Spectrometer, etc…
* Software Systems: Experience using ERP software (e.g., Oracle)
* Automation/AI: Experience in test Automation and AI-driven
* Problem Solving: Perform root cause investigation of issue and propose potential CA Soft Skills
* Attention to Detail: Critical for spotting minor deviations that could impact patient safety or device performance.
* Analytical Problem Solving: Ability to evaluate technical data to resolve manufacturing anomalies.
* Cross-Functional Communication: Capability to effectively collaborate with Production, R&D;, and Procurement departments regarding quality issues.
* Prioritization/Organizational: Good prioritizing, organizational, interpersonal, communication and analytical skills Typical Requirements
*
Education:
Bachelor’s degree in Biomedical Engineering, Materials Science, Biotechnology, Chemistry, or a related technical discipline.
*
Experience:
1–3 years of proven experience in a quality assurance/control role within a regulated environment (Medical Devices or Pharmaceuticals).
* Languages: Professional proficiency in English (both written and spoken) for reviewing standards, files, and supplier documentation. #J-18808-Ljbffr
* Review documentation for SOP, Test Instruction and Calibration Procedure.
* Final review & release of Medical Device History Records (DHRs).
* Identify and initiate NCR internal and external (Supplier).
* Own and drive CAPA to completion.
* Assist with incoming inspection, in process inspection, returns & and continuous improvement initiatives.
* Support packaging control and change.
* Perform visual, dimensional, and functional inspections on in-process components and finished product lots.
* Investigate and valuate customer complaints.
* Monitor and maintain the calibration and maintenance schedules for laboratory instruments and production measurement gauges.
* Expertise of technical instrument for chemical analysis included result interpretation.
* Initiate and support change control ECR/ECO.
* Participate in cross-functional QA meetings and provide quality support.
* Assist the Quality Assurance during internal audits and external inspections by Notified Bodies or regulatory authorities (e.g., BSI, FDA etc).
* Prepare deck for QA Operations slides, including trending and escalation. Job RequirementsTechnical Skills
* Regulatory Knowledge: Understanding of ISO 13485 (Medical Devices – Quality Management Systems) and MDR 2017/745 regulations.
* Measurement Tools & Instruments for chemical analysis laboratories: Proficiency with calipers,
micrometers, optical comparators, microscopes, HPLC, GC, pH-meter, IR, Spectrometer, etc…
* Software Systems: Experience using ERP software (e.g., Oracle)
* Automation/AI: Experience in test Automation and AI-driven
* Problem Solving: Perform root cause investigation of issue and propose potential CA Soft Skills
* Attention to Detail: Critical for spotting minor deviations that could impact patient safety or device performance.
* Analytical Problem Solving: Ability to evaluate technical data to resolve manufacturing anomalies.
* Cross-Functional Communication: Capability to effectively collaborate with Production, R&D;, and Procurement departments regarding quality issues.
* Prioritization/Organizational: Good prioritizing, organizational, interpersonal, communication and analytical skills Typical Requirements
*
Education:
Bachelor’s degree in Biomedical Engineering, Materials Science, Biotechnology, Chemistry, or a related technical discipline.
*
Experience:
1–3 years of proven experience in a quality assurance/control role within a regulated environment (Medical Devices or Pharmaceuticals).
* Languages: Professional proficiency in English (both written and spoken) for reviewing standards, files, and supplier documentation. #J-18808-Ljbffr