Medical Device Scientist

SUMMARY

Responsible for supporting laboratory operations through protocol preparation, technical consultation, quality improvement initiatives, and team training.

This role works closely with customers, sales teams, and laboratory personnel to ensure accurate test performance, compliance with MS ISO/IEC 17025:2017, and timely resolution of technical issues. The position requires strong analytical skills, communication ability, and a commitment to continuous improvement in microbiological testing services.

RESPONSIBILITIES

• Prepare customized test protocols according to customer requirements, industry standards, and laboratory capabilities.
• Participate in meetings and technical discussions with customers to understand needs and provide expert recommendations.
• Assist customers in resolving technical issues related to testing methods, standard compliance, or test feasibility.
• Liaise with the Sales Team to support customer inquiries involving test information, standard requirements, special requests, and urgent sample handling.
• Investigate issues related to test results, equipment malfunction, or procedural deviations, and ensure timely resolution.
• Analyze unexpected or nonconforming results, document findings, and initiate necessary corrective and preventive actions (CAPA).
• Participate actively in internal quality improvement programs and audits to maintain compliance with MS ISO/IEC 17025:2017.
• Drive implementation of best practices and innovative testing techniques to enhance laboratory performance.
• Provide coaching and guidance to junior staff on MS ISO/IEC 17025:2017 requirements, documentation standards, and laboratory best practices.

EDUCATION

• Bachelor’s degree in microbiology, Biotechnology, Biomedical Science, or related field.
• Experience in microbiology testing, preferably in an ISO/IEC 17025 accredited laboratory or medical device testing environment.
• Strong understanding of laboratory quality systems, documentation, and CAPA processes.
• Good communication and problem solving skills for customer interaction and internal coordination.
• Previous experience in Medical Device is an added advantage

SKILL & COMPETENCY

• Technical knowledge in microbiology and laboratory procedures
• Strong analytical and troubleshooting ability
• Customer focused communication
• Understanding of MS ISO/IEC 17025:2017 requirements
• Attention to detail and documentation accuracy
• Ability to collaborate cross functionally (Sales, QA, Operations)