Certifier II (Medical Devices)

CSA Testing & Certification; Bengaluru; On-site; INR 700,000 - 1,000,000; Full time

Job summary

CSA Testing & Certification in Bengaluru is looking for a Product Safety Certifier II to manage certification projects for medical devices. Your role will involve ensuring compliance with safety standards, preparing quotations, and working closely with clients. A Bachelor's or Diploma in Engineering is required, along with experience in safety standards for medical devices. You will handle complex projects, supporting CSA's global certification programs while fostering client relationships.

Qualifications

• 5 years of job-related experience with a Bachelor's Degree or 7 years with a Diploma.
• Thorough knowledge of X-ray related standards.
• Some experience in Testing, Inspection, and Certification (TIC) ideally in medical.

Responsibilities

• Manage certification projects ensuring compliance with safety requirements.
• Support current clients and develop new client opportunities.
• Prepare project quotations and explain certification programs.

Skills

Knowledge of safety standards for North America

Experience in TIC

Risk Management understanding

Education

Bachelor’s Degree in Engineering

Diploma in Engineering

Job description

Product Safety 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), ensuring safe products while meeting clients’ needs efficiently and effectively. It requires extensive knowledge of X‑ray related standards (60601‑1‑3, 2‑28, 60601‑2‑43, 60601‑2‑45, 60601‑2‑54) and involves interpreting standards, processes, and procedures, making technical decisions based on advanced knowledge, training and experience 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.

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 [e-mail] if you require accommodation in the interview process.