Process Technician Medical Device Manufacturing Overview The Process Technician supports manufacturing operations by ensuring that production equipment, processes, and procedures run safely, efficiently, and in compliance with medical device quality standards (ISO 13485, FDA 21 CFR Part 820).
Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants.
The role involves troubleshooting production issues, sustaining processes, performing equipment setup, and collaborating with engineering teams to improve product quality and throughput.
For more information contact: Mark or Key Responsibilities 1.
Production Support Operate, monitor, and troubleshoot production equipment used in the manufacturing of medical devices.
Perform equipment setups, changeovers, calibrations, and routine maintenance.
Ensure processes meet established performance and quality standards.
2.
Process Monitoring & Documentation Record process data, equipment parameters, and production results in accordance with Good Manufacturing Practices (GMP).
Maintain accurate documentation including batch records, logbooks, and maintenance reports.
Support root-cause investigations for deviations, non-conformances, and equipment failures.
3.
Quality & Compliance Ensure all operations comply with ISO 13485, FDA regulations, and internal quality systems.
Perform in-process quality checks and ensure adherence to specifications.
Report and escalate quality or safety issues immediately.
4.
Continuous Improvement Work with Process Engineers to optimize processes, reduce waste, and improve yields.
Participate in process validation activities (IQ, OQ, PQ).
Identify opportunities for automation, efficiency improvements, and cost reduction.
5.
Equipment & Material Handling Set up and verify that tools, molds, jigs, and fixtures are correctly installed.
Ensure proper handling, labeling, and storage of materials and components.
Support preventive and corrective maintenance activities.
6.
Safety Follow all safety procedures, including lockout/tagout, chemical handling, and machine operation.
Maintain a clean and organized work area following 5S principles. xsokbrc
Qualifications Education Diploma or Degree in Engineering, Manufacturing Technology, Mechatronics, or related field.
Experience 13 years of experience in manufacturing; medical device or pharmaceutical industry preferred INDTRAC Skills: maintenance electrical mechanical PLC trouble shooting fault finding
