Certifier II (Medical Devices)

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:

Product Safety Certifier II (Medical Devices)

Job Summary:

CSA Group, Bangalore has an opening for a Product Safety Certifier-II 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 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 CSAs global certification programs

Responsibilities:

PERFORMANCE

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

Handles a wide spectrum of projects including those that are complex generating high revenue levels

Delivers assigned projects / tests within agreed timescales the majority of the time

Demonstrates the ability to accurately manage project costs within the agreed budget

Able to maintain good productivity in line with company expectations

Demonstrates technical competence to review the work of others per divisional quality documents

Demonstrates technical competence to perform witness testing per divisional quality documents

Reviews test data and reports and authorizes application of the CSA Mark

Prepares and / or signs Certification Reports and Certificates of Compliance

Provides client with assistance in solving problems / failures without divulging proprietary information

CUSTOMER

Works with sales to support current clients and develop new client opportunities to support growth

Prepares project quotations for cost and time

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

TESTING

Performs within established DQD guidelines

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

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

Able to demonstrate experience of performing common testing within CSA laboratories

Makes field trips and witnesses test work at manufacturer's facilities as required

SELF DEVELOPMENT

The Certifier II is subject to internal audits for compliance and competence

Participates in CSA Group Continuous Improvement and Innovation projects

Makes recommendations on new programs / equipment to expand core capabilities

Generates ideas to improve laboratory safety

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

EDUCATION

Bachelors Degree in Engineering with likely 5 years of job related experience

Must Haves:

Thorough knowledge of safety standards for North America, Canada & IEC particularly for Medical devices & testing procedures

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 talentacquisition@csagroup

org if you require accommodation in the interview process