Paramvir Singh Email & Phone Number

Kitchener, On, Ca

Mississauga, Ontario, Canada

-Conducting performance testing of medical devices to ensure they meet required specifications and standards, and identifying opportunities for improvement in product design.-Developing risk management strategies to minimize the potential for device failure or malfunction and collaborating with cross-functional teams to implement risk management processes.-Developing and implementing quality assurance processes and procedures to ensure that medical devices meet regulatory and customer requirements.-Working closely with product development teams to ensure that product design and development processes comply with regulatory requirements and industry best practices.-Conducting root cause analysis of product performance issues to identify the underlying causes and develop corrective actions.-Developing and executing product validation plans to ensure that medical devices are safe, effective, and meet customer requirements.-Creating and maintaining documentation related to product performance testing, risk management, and quality assurance processes.-Ensuring that medical devices meet regulatory requirements and working with regulatory agencies to obtain necessary approvals.-Collaborating with cross-functional teams including design, development, quality, regulatory, and clinical teams to ensure successful product development and launch.-Identifying opportunities for continuous improvement in product performance, risk management, quality assurance, and regulatory compliance processes.

Mississauga, Ontario, Canada

Product Investigations:-Conducted thorough investigations of customer complaints and reported adverse events related to medical devices.-Analyzed data and determined root causes of issues with medical devices.-Developed and implemented corrective and preventive actions (CAPAs) to address identified problems.-Collaborated with cross-functional teams, including Manufacturing, R&D, and Regulatory Affairs, to resolve product issues and ensure compliance with regulatory requirements.-Provided regular updates to management on the status of product investigations and the effectiveness of implemented CAPAs.Post-Market Surveillance:-Monitored and analyzed post-market data to identify potential safety and quality issues with medical devices.-Conducted periodic reviews of product performance data to assess product safety and effectiveness.-Conducted risk assessments of medical devices to identify and mitigate potential risks.-Developed and implemented post-market surveillance plans to ensure ongoing monitoring of product performance and safety.-Prepared reports on post-market surveillance findings and presented them to management and regulatory agencies as needed.Overall, my goal as a Quality Engineer was to ensure the safety and effectiveness of medical devices by identifying and addressing any product issues through complaint investigations and post-market surveillance.

Ontario, Canada

-Conducted quality inspections on in vitro diagnostics products during the manufacturing process, ensuring adherence to specifications and standards.-Implemented and maintained quality control procedures for wafer engineering , cartridge printing and assembly to improve product reliability and reduce defects.-Collaborated with cross-functional teams to identify root causes of quality issues and implemented corrective actions to prevent recurrence.-Led process improvement projects to optimize manufacturing processes, resulting in increased efficiency and reduced costs.-Developed and executed quality assurance plans for new product introductions, including validation and verification activities.-Conducted risk assessments and implemented risk mitigation strategies to ensure product safety and compliance with regulatory requirements.-Conducted internal audits to assess compliance with quality management systems and implemented corrective actions as necessary.-Provided training and guidance to manufacturing personnel on quality control procedures, ensuring consistent understanding and implementation across the organization.-Analyzed and interpreted data from quality inspections and tests, preparing comprehensive reports for management review.-Maintained and updated quality documentation, including standard operating procedures, work instructions, and quality records.-Implemented statistical process control techniques to monitor manufacturing processes and ensure process stability and capability.-Contributed to the design and development of new manufacturing equipment and processes, considering quality and reliability requirements.

- Planned and led production engineering processes. Improved manufacturing efficiency, achieved maximum production/ financial objectives, and optimized operational strategies.- Performed standard methods of inspection, pressure tests, and preventative maintenance. Communicated ideas for efficiency and continuous improvement with senior management.- Analyzed cycle times, maintaining correct process sequences, and regularly made use of drafting tools.

India

- Analyzed manufacturing processes, participated in continuous improvement, designed new products, checked quality, and selected materials according to manufacturing processes.

Bengaluru, Karnataka, India

- Designed/ analyzed the structure of a delta wing for a multirole light fighter. Performed research on honeycomb structure tailfin pieces, and recommended the use of carbon composites (resulting in a 20% reduction in parts).

Masters Of Engineering, Manufacturing And Materials

Master of Engineering (M.Eng.) in Manufacturing and Material Engineering *Completed an advanced program focusing on the integration.

Bachelor'S Degree, Mechanical Engineering

*Comprehensive Knowledge: Acquired a strong foundation in Mechanical Engineering, covering a diverse range of topics including.

Diploma In French, French Studies

•Cleared French Language test Delf A1 and A2 •Completed intermediate french course