Andre Kindsvater, Senior Consultant, Quality Assurance & Regulatory

Andre is based in our Vancouver, British Columbia office and serves Emergo clients throughout North America. He has developed, maintained and upgraded quality systems in compliance with the US FDA Quality System Regulation, ISO 13485:2003 and the additional requirements of Canada's Medical Device Regulations (CMDR). He has extensive experience developing CAPA procedures, conducting audits, compiling 510(k) submissions and maintaining the compliance of Quality Management Systems with international Standards and regulations.

Andre is particularly experienced with software, having spent more than 10 years as a Systems & Software Engineer. Thus, he provides a wealth of expertise for Emergo clients who manufacture imaging equipment or any other medical devices with a software component.

EXPERIENCE:

Director of Quality Assurance, Xillix Technologies Corp. (2005-2006)

• Maintained and upgraded the Quality System complying with FDA QSR (21 CFR Part 820) and ISO13485:2003.
• Monitored, managed and verified Corrective and Preventive Actions (CAPA).
  
• Reviewed design documentation and participated in design reviews.
• Conducted risk management assessments, conducted internal audits and coordinated resulting corrective actions.
• Oversaw tool control and specifications (change) control.
• Provided ongoing quality training and education and submitted regular reports to senior management,
• Maintained all quality records,
  
• Coordinated external audits (FDA & ISO) and contributed to regulatory submissions.

Director of Quality Assurance and Regulatory Affairs, VSM MedTech Ltd. (1999-2005)

• Developed, installed and maintained a complete Quality System complying with FDA QSR and ISO13485 first for the parent company and then later again for a 120-employee acquisition, including a Quality Manual and all required SOPs, education and training, and establishment of all required files and records.
• Obtained certification to ISO 13485 for both quality systems from BSI and UL/UK, then later combined the two quality systems into a single QMS.
• Obtained and maintained Establishment Registrations and Device Licenses from regulatory agencies in Canada, US and European Union.
• Compiled and submitted FDA 510(k) submissions and compiled Technical Files to obtain CE Marking.
• Participated in the lean manufacturing program; overseeing the 5S+1 initiative.
  

Quality Assurance Manager Xillix Technologies Corp. (1991-1999)

• Designed, implemented and maintained a complete FDA-GMP compliant quality system then adapted it to the new FDA-cGMP (21 CFR 820).
• Defined required processes and wrote all necessary standard operating procedures.
• Developed and documented a formal design control process including hazard analysis.
• Maintained the quality system by monitoring and managing all processes and records.
• Compiled the technical construction file for CE Marking.
• Wrote manufacturing and quality system sections for PMA submission.
• Conducted internal audits and submitted regular reports to senior management.
• Established and monitored all corrective actions resulting complaints, problems and audits.
• Reviewed and coordinated change controls.
• Hosted external audits and ensured completion of resulting corrective actions.
  

Senior Software Engineer, Soft Set Technologies Inc. (1989-1990)

• Specified, designed and implementated user interface for a Macintosh-based CASEtool programmed using object-oriented Pascal and MacApp.
• Installed and performed basic software quality procedures such as formal module testing.
• Managed project library and version control.

Software Engineer Wagner Engineering Ltd. (1987-1989)

• Designed and coded PID control software for naval autopilots, including console I/O as foreground/background real time system in C and Assembler.
• Designed and coded a user interface for a commercial autopilot using a Real Time Kernel.
  

Systems and Software Engineer, Kinai Technologies Inc. (1986-1987)

• Designed a 8085-based user programmable controller for satellite and solar tracking.
• Coordinated the hardware and software staff for the development of a Video Information System.

Project Engineer, Oasis Oil Company (1985-1986)

Product Engineer MacDonald, Dettwiler & Associates (1982-1985)

Sessional Lecturer/Research Assistant & Consultant UBC (1979-1982)

Field Service Engineer, Digital Equipment Corp. (1977-1979)

Lab Technician (Lab Tech), (1966-1975)

AREAS OF EXPERTISE:

Medical Devices:

• Active medical devices
• Diagnostics
• Imaging equipment
• Lasers
• Optical
• PACS
• Software

QA & RA:

• FDA Quality System Regulation (21 CFR Part 820)
• ISO 13485:2003
• Canadian Medical Device Regulations (CMDR/CMDCAS)
• Medical Devices Directive (MDD, CE Marking)
• Auditing for QMS compliance

CERTIFICATIONS AND MEMBERSHIPS:

• ISO 13485:2003 Lead Auditor Training (BSI Management Services/RABQSA)
• Registered Professional Engineer, APEBC (Computer Science), Registration #19341.
• Senior Member, American Society of Quality (ASQ).
• Member, Institute of Electronics and Electrical Engineers (IEEE).

EDUCATION:

• Master of Science, Electrical Engineering, University of British Columbia.
• Bachelor of Computer Science (Electronics/Systems), Concordia University, Montreal.
• Lab Tech Analytical Chemistry CIBA-Geigy, Basel, Switzerland.

HOME BASE:

• British Columbia, CANADA