Product Safety Certifier - Healthcare

Overview

Manages product safety certification projects for healthcare devices.

Key Responsibilities

• test documentation
• project management
• certification review
• report review
• client support
• status reporting

Tasks

-Makes recommendations on new programs / equipment to expand core capabilities. -Provides client with assistance in solving problems / failures without divulging proprietary information. -Evaluates and qualifies companies in the administration of Certification Programs. Reviews customer test methods and systems; reviews new / old product designs and all applicable documentation. Ensures all test equipment and quality procedures are within guidelines. Provides technical briefings on new and existing requirements. Authorizes application and / or removal of the CSA Mark. -Provides technical information service to external and internal customers including those forwarded by the Client Service Center. Liaises with customer in design stage to ensure requirements of national / international standards are met without compromising confidentiality. -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. -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. -Provides client feedback to Managers, Team Leader or Sales representatives, as appropriate. -Keeps the Product Group Manager or Team Leader or Assistant Operations Manager informed of project status as required, pointing out major problems and non-compliance. -Prepares project quotations for cost and time. Classifies product by use, environment and function. Determines applicable requirements / test / standards. Determines sample requirements and method / location for testing / evaluation best suited to customers’ needs. -Reviews test data and reports and authorizes application of the CSA Mark. Prepares and / or signs Certification Reports and Certificates of Compliance. -Participates in CSA Group Continuous Improvement and Innovation projects. -Explains the different product certifications programs available to clients and the requirements for control of production. -Works with sales to support current clients and develop new client opportunities to support growth -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. -Provides necessary guidance to Lab Technicians to ensure proper application of requirements and data collections methods are in line. -The qualified Certifier is accountable for including the Technical Advisor or Certification Specialist in product / technical discussions that are unique to CSA or to the experience of the individual. This aids the Technical Advisor and Certification Specialist to further advance consistency of practices and to provide guidance at the front-end of the process. -Delivers assigned projects / tests within agreed timescales the majority of the time -Generates ideas to improve laboratory safety. -Makes field trips and witnesses test work at manufacturer's facilities as required. -Performs within established DQD guidelines. -Handles a wide spectrum of projects including those that are complex generating high revenue levels

Requirements

• engineering degree
• certified technologist
• journeyman electrician
• csa standards
• microsoft office
• problem solving

What You Bring

-High level of interpersonal and communication skills; customer service skills -Demonstrate the ability to confidently and clearly communicate, explain findings, test results and technical decisions to others, including customers and other engineers. -Able to work unsupervised, in a team-based work environment -Strong organizational, time and project management skills -Demonstrates technical competence to review the work of others per divisional quality documents -Able to maintain good productivity in line with company expectations -Certified Engineering Technologist, Journeyman Electrician or equivalent industry experience with likely 3 years of related experience -Knowledge of CSA programs and services -Has a good knowledge of the clauses and tests within the standards they support and can demonstrate application across multiple product types. -The Certifier II is subject to internal audits for compliance and competence. -Demonstrates the ability to compile evaluation record, data and summary test results into forms, templates and checklists without the need for supervision. -Knowledge of CSA, UL and IEC Standards -Demonstrates technical competence in 2 or more product qualification competencies -Demonstrates the ability to correctly interpret the results from the tests with only minimal guidance and supervision -Demonstrates technical competence to perform witness testing per divisional quality documents. -Able to demonstrate experience of performing common testing within CSA laboratories -Computer proficiency (Microsoft Office) -Bachelor’s Degree in Engineering with likely 3 years of job related experience or -Strong problem-solving ability; detail oriented -Demonstrates the ability to accurately manage project costs within the agreed budget -Can explain to others the standards they are competent in

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About Csa Group

-Through its non-profit standards arm and commercial testing, inspection, and certification subsidiaries, it generates revenue while advancing technical standards. -Typical projects include certifying household products, industrial equipment, energy systems, and medical devices to rigorous safety and performance standards. -Sector specialisms span quality codes & standards, testing & certification, energy efficiency, cybersecurity, industrial and hazardous locations, medical and laboratory equipment, and building products. -Notably accredited by the Standards Council of Canada, its iconic registered mark signals independent validation of safety and compliance. -An unusual fact: its testing arm funds its standards mission, enabling a self-sustaining model blending commercial and public good.

Sector Specialisms