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서울특별시, 대한민국
Onsite
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.
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