Experience

Genevant Sciences

• Canada
• Biotechnology
• 1 - 100 Employee

• • Jul 2020 - Present

• • Aug 2018 - Jul 2020



Verathon

• United States
• Medical Equipment Manufacturing
• 400 - 500 Employee

• • Nov 2015 - Jul 2018

• • Jun 2015 - Nov 2015

  Oversee the Quality Assurance team at Verathon Medical Canada to ensure conformity to industry quality and regulatory standards/requirements associated with medical device manufacturers. Responsible for the effectiveness and efficiency of the Quality Management System. Manage and support various control systems that ensure consistent quality standards are achieved within areas such as design control, receiving inspection, production, finished goods, final packaging, Material Review Board, supplier evaluation and the CAPA system. Assist the integration of Quality Engineering into design and production processes to ensure quality and operational goals are met. Provide effective quality leadership during internal and external inspections. Support the transparency, visibility and monitoring of common quality metrics across the global organization. Collaborate with new product development to establish product testing requirements and processes. Show less

• • Jan 2015 - May 2015

  Directly responsible for overseeing and supporting the Quality function across the manufacturing value streams. Direct supervision of the quality control functions that support incoming product inspection, non-conforming product, QA final release and Calibration/Preventive Maintenance. Primary product line responsibility from design transfer to manufacturing and sustaining engineering. Monitor manufacturing performance trends and customer data to drive the implementation of corrective actions. Setup and monitor the performance of new product validation protocols to ensure product conformity to specification and all quality standards. Show less

• • Oct 2013 - Jan 2015

  Responsibilities include: primary product line responsibilities from new product development through design transfer to manufacturing and sustaining engineering; define Quality and Engineering requirements; support the Quality Management System and maintain compliance to relevant standards; deployment and development of IQ, OQ, PQ for production product transfer; perform failure Investigations and other CAPA related activities; product and process validations; internal audits; tolerance analysis on mechanical and electrical assemblies. Show less



Sorin Group

• Italy
• Medical Equipment Manufacturing
• 300 - 400 Employee

• Sr. Quality Assurance Engineer

  • Feb 2011 - Oct 2013

  Develop and implement quality procedures specific to area of responsibility. Ensure compliance to all quality policies through training, coaching and auditing. Investigate complex quality problems and develop thorough and practical engineering solutions. Perform all quality activities related to equipment and process validation. Develop and implement quality procedures specific to area of responsibility. Ensure compliance to all quality policies through training, coaching and auditing. Investigate complex quality problems and develop thorough and practical engineering solutions. Perform all quality activities related to equipment and process validation.



Corza Wound Closure

• Medical Device
• 100 - 200 Employee

• Quality Assurance Specialist

  • Mar 2009 - Feb 2011

  Medical Device Quality Assurance Specialist, focusing on Quality Systems, NCRs, CAPAs, risk assessment, manufacturing processes, employee training and internal audits. Medical Device Quality Assurance Specialist, focusing on Quality Systems, NCRs, CAPAs, risk assessment, manufacturing processes, employee training and internal audits.



BC Cancer

• Canada
• Hospitals and Health Care
• 700 & Above Employee

• QA Officer/Documentation Coordinator

  • Jul 2005 - Feb 2009

  My time here was spent within the Investigational Drug Program of the Advanced Therapeutics Dept. of the BC Cancer Research Centre. My time here was spent within the Investigational Drug Program of the Advanced Therapeutics Dept. of the BC Cancer Research Centre.



Inex Pharmaceuticals

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Unit Associate

  • Jun 2002 - Dec 2004



Response Biomedical Corp.

• Canada
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Product Development Associate

  • 2000 - 2001