Job Descriptions
· Supports medical device development & manufacturing operations including but not limited to
· QMS/DMR development;
· Root cause investigations for corrective actions;
· Implementation of corrective actions;
· Analyse quality metrics for corrective and preventive actions: and
· Change records and assurance of proper record control.
· Develops test protocols and reports for the validation and/or re-validation of equipment, processes, test methods, and computer systems.
· Develops sampling plans, determines sample sizes, and perform data analysis using various statistical tools including but not limited to regression analysis, t-test, ANOVA, and process capability indices.
· Collaborates with manufacturing engineering, production, purchasing, and quality assurance functions to drive process excellence.
· Technical liaison to external medical device customers.
· Coordinate Internal Audit / Supplier Audit Programme
· Technical reviewer of engineering changes related to product specifications, process parameters, methods and equipment.
· Performs as technical writer responsible for the development of test protocols, test reports, work instructions, and standard operating procedures.
· Assist in maintaining certification and regulatory compliance to ISO 13485, QSR , Medical Device Directive Requirements and any regulatory standards as applicable.
· Supports Quality Assurance in the review, analysis, and reports on process and product performance to management.
· Conduct new employees’ orientation (NEO) training for Quality Management System and 6S for newly joined employees.
· Other ad-hoc tasks assigned by immediate supervisor.
Requirement:
• Minimum Degree in Mechanical/ Mechatronic Engineering.
Experience:
· Minimum 3-5 years relevant experience as a Quality Professional, preferably in ISO 13485 environment.
· Good understanding in the implementation of QMS (ISO 13485), Quality Assurance and Quality Control methodology.
· Regulatory experience in GMP(Good Manufacturing Practice) procedures
Skills :
· ISO 13485 Internal Auditor Trained
· Six-sigma trained with strong engineering fundamentals.
· Strong attention to details and able to work under tight deadlines.
· Ability to multi-task, prioritize tasks and quickly adjust in a rapidly changing environment