Product Assessor – Medical Devices

Company Description

We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. 

Job Description

• Product Assessor will conduct technical file reviews of Class 11a/11b and/or Class III and approve or raise queries based on technical and procedural knowledge.
• Ensure reviews are technically sound and in compliance with all applicable regulations, standards, guidelines, and competent authority expectations.
• Ensure that the highest level of service is provided through efficient service delivery and those customer requirements are met while adhering to SGS Policies, procedures, and processes.
• As a member of the Global Medical Device office (MDO) to minimize risks associated with medical device certification. Act as a support/leader to the defined group in terms of technical assistance, facilitate training, communication, assistance with widening the codebase.
• Maintain personal competence and development in qualified specialist areas on an ongoing basis
• Project manage reviews as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards
• To support/assist on queries raised from the review
• Work at all times to adhere to KPI’s set as an individual and within a team
• To ensure personal competency is maintained to be able to review technical files and technical documentation
• Maintenance of MDD/MDR or IVD/IVR Product Assessor status

Qualifications

• Bachelor’s degree in a related discipline (i.e., medicine, pharmacy, engineering, or other relevant sciences
• Minimum 4 years of experience in the field of healthcare products or related industry (manufacturing, auditing, or research)
• Active Medical Devices knowledge:
• stand-alone software devices, etc. through designing, manufacturing, or testing of such devices;
• non-implantable device for monitoring,
• non-implantable device for monitoring vital physiological parameters,
• non-implantable devices utilizing hyperthermia / hypothermia,
• non-implantable surgical device
• non-implantable devices for wound and skin care
• Minimum 2 years in the design, manufacture, testing, or use of the device or technology to be assessed or related to the scientific aspects to be assessed
• A broad range of codes and previous Technical File review experience
• Ability to travel across Canada and the US (Up to 50%)

Additional Information

SGS Canada is an equal opportunity employer and we are committed to achieving greater accessibility by providing accommodation for people with disabilities during our hiring process. Accommodations are available on request for qualified candidates during each stage of the recruitment process.

Please note that candidates applying for Canadian job openings should be authorized to work in Canada

#SGSSJ

Read Full Description