Intertek
From Intertek's careers page
Status: listed on the employer's own careers page when we last checked (daily). Confirm on their site before applying.
Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices and over 46,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains. Intertek Total Quality Assurance expertise, delivered consistently with precision, pace and passion, enabling our customers to power ahead safely. True to the spirit of our founders, we lead the industry with unparallel ATIC services. The spirit ignited by our co-founder Thomas Alva Edison who gave one of the biggest inventions to the world - lightbulb, has guided all the Intertekers for 130 years and we continue to discover the Edison in ourselves every day! The opportunity for you to be a part of this heritage is right there, join our ever-better journey it’s time to unveil your destiny.
What we are looking for in you?
Performing electrical safety testing and evaluation on a variety of Medical Devices to the provisions of U.S., Canadian and other International product safety standards such as IEC /ANSI/CSA 60601-1 and its collateral and Particular standards and writing reports; and communicating with clients.
SUCCESS FACTORS
Operations Excellence
Responsible for performing test of products in accordance with applicable standards. Core tests include but are not limited to: Medical product Safety testing (IEC/ EN 60601-1 3.1 edition), Collateral Standards ( IEC 60601-1-X) and Performance Standards ( IEC 60601-2-X & IEC/ISO 80601-2-X).
Test experience in Medical device testing and requirements are preferable.
Knowledge on all Basic and product standards
Responsible for preparing test plan for products containing different test parameters, relevant test method/standard & requirement / limit / acceptance criteria of each test.
Ensure quality of service is maintained throughout the certification and inspection process
Responsible for occupational safety and housekeeping
Ensure quotes and commitment dates are and in line with team targets
Assist in conducting audit time to time.
Read and determine applicability of national codes and standards clauses for the EUT(equipment under test).
Read and understand schematics and manufacturing instructions.
Validate the project scope and sample applicability.
Under scope of the project, identify and locate test instruments and equipment required for testing.
Follow established test plan.
Set up and operate EUT; perform and document simple repairs on EUT as needed.
Conduct thorough construction review; document test results.
Perform testing of products in accordance with applicable standards. Core tests include, but are not limited to: Power input or rating test, leakage current, dielectric, temperature, pressure, stability, mechanical hazard, flammability, abnormal and single faults, ingress protection Testing, rain, radiation, sound, laser etc.
Knowledge of ISO 14971 and perform risk management review to IEC 60601-1, usability to IEC 60601-1-6 and 62366, software to IEC 62304 and other related process-based standard file reviews.
Support Operations Manager/Business Head in routine activities.
Maintaining TAT of Testing
Quality of testing to be at par with defined standards
Stakeholder Management
Provide technical assistance to clients and manage and resolve customer issues to ensure services delivered result in a high level of customer satisfaction
Co-ordinate with third party test labs to get quotation, test slots & test reports
Co-ordinate with INTERTEK overseas test labs to get quotation, test slots & test reports
Travel to third party test lab to witness the safety testing
Coordination with respective regulatory authorities.
Ongoing coordination with support functions
Tracking of NPS
Consistent adherence to regulatory guidelines
We are Looking for You with
Qualification
Bachelor of Electrical/ Electronic Engineering / Bio Medical Engineering
Technical Certifications
Exposure to applicable testing and certification standards
3 to 5 Years
Expertise at
Exposure to applicable testing and certification standards.
Should have an experience of testing multiple products
NOTE: In addition to the pre-qualification criteria provided in the above job posting/opportunity, please note that the concerned employee must have completed at least 24 months in Intertek India prior to applying for the above job posting/opportunity.
As mentioned above.
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