Job Description:
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 Requirements:
Technical 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.
Operating Company:
Kerr
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