Certifier II (Medical Devices)

Job Summary:

CSA Group, Bangalore has an opening for a Product Safety Certifier-II in the 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 related standards (60601-1-3, 2-28, 60601-2-43, 60601-2-45, 60601-2-54).

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

• 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:

• Bachelor's Degree in Engineering with likely 5 years of job related experience / Diploma in Engineering with likely 7 years of job related experience

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 standards (60601-1-3, 2-28, 60601-2-43, 60601-2-45, 60601-2-54).
• 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

Preferred:

• 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