Product Safety Certifier 1 - Medical

Employment Status:

Regular

Time Type:

Full time

BUILDING A WORLD CLASS TEAM STARTS WITH YOU

At the heart of CSA Group is a vision: making the world a better, safer, more sustainable place. It's been part of our mission for nearly one hundred years: from the first engineering standard for railway bridges developed in 1919, to more than 3,500 standards, codes & related products today.

Headquartered in Canada, with a global footprint of more than 30 labs and offices across Europe, Asia and North America, CSA Group tests, inspects and certifies a wide range of products - from every day househould items to leading edge technology-to meet exacting requirements for safety, performance and environmental impact.

Our employees take pride in making a difference in people's lives through the work that we do. We're looking for people like you to help make it happen.

Job Summary:

CSA Group, Korea has an opening for a Product Safety Certifier-I in Healthcare segment. This position is responsible for providing high quality certification in accordance with Medical devices product safety standards (e.g. IEC/ANSI AAMI / CSA 60601-1 and its Collateral and Particular standards) which meets the clients’ needs in the most efficient and effective manner possible, while ensuring safe products. This position primarily requires knowledge of X-Ray, HF surgical equipment standards (60601-1-3, 2-2, 2-28, 60601-2-43, 60601-2-45, 60601-2-54) and 60335 standards.

This activity requires interpretation of standards, processes and procedures. Makes technical decisions based on a high degree of knowledge, training and experience on certification and testing to maintain the integrity of CSA’s global certification programs.

Responsibilities:

PERFORMANCE

-  Handles a narrow spectrum of projects generating moderate revenue levels

-  Demonstrates a good understanding of the company certification process, accreditation requirements and governing quality management procedures.

-  Demonstrates understanding of and the ability to accurately perform all elements of evaluation (contract review, evaluation and determine a test plan) under supervision.

-  Demonstrates understanding of all elements involved in testing for specific standards (select proper tests, understand past fail criteria and rational) under supervision.

-  Conducts construction evaluation, ensuring the unit complies with the construction section of the standard; identifies rationale for compliance or non-compliance.

-  Collaborates with Lab Technician to create a work order which test are required and; the order of the tests and the number of samples required.

-  Classifies product by use, environment and function. Determines the applicable requirements / test / standard. Determines sample requirements and method / location for testing evaluation best suited to customers' needs. Conducts pre-assessment with mentor assistance, of equipment to ensure the unit is equipped with the proper components and agrees with the construction indicated on the work order and submittal information.

-  Works with mentor to ensure completion or projects within time frame deadlines. With mentor assistance, evaluates products against requirements of national and / or international standards. With assistance, prepares work orders for the test program. Works in collaboration with Lab personnel to determine applicable tests. Assists test personal and perform test when required.

-  Prepares Findings Communications, Certification reports, Certificates of Compliance and other related CSA documentation for the mentor

CUSTOMER

-  As appropriate, suggests to  sales team  new client opportunities to support growth

-  Prepares project quotations for cost and time. Classifies product by use, environment and function. Determines applicable requirements / test / standards. With supervision, determines sample requirements and method / location for testing / evaluation best suited to customers’ needs.

-  Explains the different product certification programs available to clients and the requirements for control of production.

-  Provides client feedback to mentor, Manager, Team Leader, Project Holder or Sales Rep as appropriate.

TESTING

-  Performs within established DQD guidelines.

-  Prepares Test Lab Work Orders and Special Testing Documentation.

-  Provides necessary guidance to Lab Technicians to ensure proper application of requirements and data collections methods are in line.

-  Set-ups and operates all test equipment within an assigned product area with supervision.

-  Demonstrates an understanding of the test method for common tests and ability to correctly specify a test plan.

-  Demonstrates the ability to record and report evaluation, tests and calculations capturing all relevant data required by each standard with supervision.

-  Conducts witness test programs at manufacturer’s accredited laboratory as needed with supervision.

SELF DEVELOPMENT

-  Strives to become more knowledgeable in national / international standards through research of standards, documentation, bulletins and technical articles in area of specialty. Participates in formal, informal, and team training events to expand his / her Certifier capabilities.

-  Seeks to understand and plan for own development needs in line with this competency matrix and the tests they are assigned to perform

-  Performs other duties as assigned by mentor, Manager, Team Leader, or Project Manager.

EDUCATION

-  Bachelor's degree in Engineering with 2 - 5 years of job related experience or

-  Diploma in Engineering with likely 3 - 6 years of job related experience

-  Knowledge of Laboratory instrumentation, including operating principles and calibration procedures, as well as general Laboratory procedures

-  Demonstrates the ability to correctly use all CSA and standard office software

-  Presents written and verbal communication in a clear manner using the appropriate template with only minimal checking by a supervisor

-  Has good interpersonal skills and works well with all members of the team, treating others with respect and promotes co-operation

-  Self-motivated and client-service oriented

-  Computer proficiency (Word processing); keyboarding 

-  Strong problem-solving skills, detail oriented, strong organizational, time, and project management skills

-  Use of various lab equipment, instruments and tools

Ability to read, interpret engineering drawings, schematics, and test data

MUST HAVES:

Thorough knowledge of safety standards for North America, Canada & IEC particularly for Medical devices & testing procedures. This position requires knowledge of X-Ray, HF surgical equipment standards (60601-1-3, 2-2, 2-28, 60601-2-43, 60601-2-45, 60601-2-54) and 60335 standards.

Some experience in TIC (Ideally within Medical), but may consider applicants with a manufacturing background

Understanding and application of Risk Management concept for a medical equipment

PREFFERED:

Knowledge of CSA certification programs and services applicable to a variety of equipment

Ideally to come from competitor with relevant knowledge / experience of this field / sector

CSA Group is an Equal Opportunity Employer and is committed to diversity, equity, and inclusion.  We prohibit discrimination and harassment of any kind based on any grounds stipulated by applicable laws. We are an organization where opportunities are based on skills and abilities, and differences are respected and valued.  Please contact us at [email protected] if you require accommodation in the interview process.