QC Lab Technician – Medical Devices
الوصف الوظيفي
Position Overview
We are seeking a meticulous and experienced Quality Control Lab Technician – Medical Devices to join our dynamic team in Riyadh, Saudi Arabia. This full-time, onsite role is ideal for professionals with a strong background in medical device quality control, laboratory testing, and compliance with international standards. The successful candidate will play a critical role in ensuring the safety, efficacy, and regulatory compliance of our medical devices through rigorous testing, documentation, and continuous improvement initiatives.
Key Responsibilities
The QC Lab Technician will be responsible for executing a wide range of laboratory activities to uphold the highest standards of quality and compliance. Core duties include:
- Testing and Inspection: Perform comprehensive physical, functional, and dimensional testing on raw materials, in-process products, and finished medical devices in strict adherence to Standard Operating Procedures (SOPs) and ISO 13485 requirements.
- Sterility and Packaging Evaluations: Conduct sterility tests, packaging integrity assessments, and other laboratory evaluations to ensure product safety and compliance with regulatory standards.
- Documentation and Reporting: Accurately record test results in laboratory records, Laboratory Information Management Systems (LIMS), or Enterprise Resource Planning (ERP) systems. Prepare detailed test reports and promptly escalate any non-conformities to the Quality Assurance (QA) team for further action.
- Equipment Management: Operate, calibrate, and maintain laboratory instruments and testing equipment to ensure precision and reliability in all testing processes.
- Compliance and Quality Assurance: Maintain strict adherence to Good Laboratory Practices (GLP) and established quality system procedures to support regulatory compliance and product integrity.
- Audit Support: Assist in internal audits by ensuring all laboratory documentation and records are up-to-date, accurate, and readily available for review.
- Investigative Support: Contribute to root cause analysis and corrective actions for product deviations, collaborating with cross-functional teams to implement effective solutions.
- Continuous Improvement: Participate in process improvements, test method validations, and validation studies to enhance laboratory efficiency and product quality.
- Team Collaboration: Provide guidance and support to junior laboratory staff, fostering a culture of knowledge sharing and professional development within the team.
Qualifications and Requirements
To excel in this role, candidates must meet the following criteria:
- Experience: A minimum of 2 to 4 years of hands-on experience in a medical device quality control laboratory environment.
- Education: A Diploma or Bachelor’s degree in Laboratory Science, Biotechnology, Chemistry, or a closely related field.
- Technical Skills: Proven expertise in laboratory testing methodologies, equipment operation, and quality documentation practices.
- Regulatory Knowledge: Familiarity with ISO 13485 standards and medical device quality requirements is highly advantageous.
- Soft Skills: Strong attention to detail, analytical thinking, and the ability to work collaboratively in a fast-paced environment.
Work Environment
This position is based in Riyadh, Saudi Arabia, and requires full-time onsite attendance. The role offers a competitive compensation package, professional growth opportunities, and the chance to contribute to impactful projects in the medical device industry. If you are a detail-oriented professional passionate about quality and compliance, we encourage you to apply and become an integral part of our quality-driven team.
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