Certifier II (Medical Devices)

Description

• Reviews test data and reports and authorizes application of the CSA Mark. Prepares and / or signs Certification Reports and Certificates of Compliance.
• Delivers assigned projects / tests within agreed timescales the majority of the time
• Makes field trips and witnesses test work at manufacturer's facilities as required.
• Provides client with assistance in solving problems / failures without divulging proprietary information.
• Provides necessary guidance to Lab Technicians to ensure proper application of requirements and data collections methods are in line.
• Generates ideas to improve laboratory safety.
• Prepares project quotations for cost and time.
• Works with sales to support current clients and develop new client opportunities to support growth
• Prepares Test Lab Work Orders and Special Testing Documentation that includes details regarding applicable sections of relevant standards, test sample plan, data collection methods and tables, Job Hazard Analysis, and any other instructions.
• Participates in CSA Group Continuous Improvement and Innovation projects.
• Explains the different product certification programs available to clients and the requirements for control of production.
• Becomes fully knowledgeable in all national / international standards through research of standards, documentation, bulletins and technical articles in area of specialty. Recommends revisions to ensure technical consistency to resolve issues of pertinent practices, processes and precedents.
• Makes recommendations on new programs / equipment to expand core capabilities.
• Independently manages certification projects concurrently ensuring compliance with all applicable safety requirements achieving completion within time frames and cost deadlines. Evaluates products against requirements of the national / international standards and precedent decisions.
• Performs within established DQD guidelines.
• Handles a wide spectrum of projects including those that are complex generating high revenue levels

Requirements

• Demonstrates technical competence to review the work of others per divisional quality documents
• Able to demonstrate experience of performing common testing within CSA laboratories
• Able to maintain good productivity in line with company expectations
• The Certifier II is subject to internal audits for compliance and competence.
• Understanding and application of Risk Management concept for a medical equipment
• Thorough knowledge of safety standards for North America, Canada & IEC particularly for Medical devices & testing procedures. This position requires knowledge of X-Ray standards (60601-1-3, 2-28, 60601-2-43, 60601-2-45, 60601-2-54).
• Ideally to come from competitor with relevant knowledge / experience of this field / sector
• Demonstrates technical competence to perform witness testing per divisional quality documents.
• Demonstrates the ability to accurately manage project costs within the agreed budget
• Bachelor’s Degree in Engineering with likely 5 years of job related experience / Diploma in Engineering with likely 7 years of job related experience
• Knowledge of CSA certification programs and services applicable to a variety of equipment
• Some experience in TIC (Ideally within Medical), but may consider applicants with a manufacturing background

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance