Manchula Sivapalan Email & Phone Number

North York, Ontario, Canada

 Ensure review and verification of process and quality documentation for devices Promote and participate in final testing and inspection of parts Supervise and assemble/fabricate components of catheter devices and transducers Lead dismantling, cleaning, assembly, and set-up of manufacturing/testing equipment Support Production Technicians with troubleshooting and resource allocation Monitor and report on production schedules Complete and ensure completion of paperwork and electronic documentation related to manufacturing/quality control processes Lead by example in cleanliness/order of work area to ensure compliance with CGMP Facilitate and maintain emphasis on health and safety of all staff according to Conavi's SOPs and legislative procedures Continuously train and educate team on process, quality, and safety documentation Manage Production Technicians, including recruitment, training, and performance management Contribute to resolution of audit identified deficiencies and performance gaps in production Support and participate in implementation of initiatives, including process improvement projects Work cross-functionally with Engineering, Manufacturing, and Quality departments to develop pragmatic solutions Contribute towards a culture of operational excellence through leading by example, adhering to good manufacturing practices, and developing strong cross-functional relationships.

North York, Ontario, Canada

 Supported quality, engineering, and manufacturing stakeholders in the uninterrupted production flow of catheters while maintaining compliance with the MDSAP ISO 13485:2016 standard. Engaged in process improvement projects to strengthen production processes, resulting in a 321% increased yield to small-batch catheter micro-assembly production over a 2-year period. Spearheaded efforts to implement a tracker system for production work order management, which standardized work order requests for each batch – resulting in an e-mail volume reduction of 433% over the last two quarters. Acting team leader and subject matter expert in medical device pouching, labeling, and packaging for sterilization and fulfillment of sales orders.

 Manufactured and repaired medical devices across multiple product lines including but not limited to, diagnostic imaging applications(X-ray), and patient monitoring devices cardiac pacemaker). Ensured availability of chemicals, equipment, and consumables following established processes and lean manufacturing practices. Performed incoming inspection and was responsible for functional testing devices as a quality control point.

Supply Chain Management

Diploma Of Education, Clinical Laboratory Science/Medical Technology/Technologist