LetsGetChecked is becoming a global leader in personal health testing. Our medical technology platform provides connectivity between customers and our global network of laboratories. We are enabling customers to order, manage and track their own clinical outcomes through a personal online account.
We are looking for a Quality Engineer to enhance our growing team. As a Quality Engineer, you’ll provide support to the Operations, Engineering and Quality Management functions. You will lead the development of Design and Development processes in-line with Medical Device/ In-Vitro Diagnostic Medical Devices Regulations for global markets and jurisdictions.
Responsibilities include, but are not limited to, the following:
- Support product design and manufacturing activities
- Represent Quality through all product and process development life cycle phases to help ensure product manufacturability, reliability and cost effectiveness.
- Provide advice based on R&D’s objectives
- Create, manage and maintain and Medical Device Files, Technical Files and Risk Management files.
- Review engineering specifications to ensure QA requirements are met
- Make sure that equipment and process validations meet FDA, Canadian and EU regulatory requirements
- Prepare reports, documents, procedures, specification’s and other such technical documents as required to ensure the success of the project
- Drives compliance cross-functionally in alignment with ISO 13485:2016, MDSAP, MDR 2017-745, IVDR 2017-746 requirements
What are we looking for?
- A Bachelor’s degree in engineering or a related field
- At least three years’ experience in a similar role in the medical device industry, experience in In-Vitro Diagnostic Medical Devices advantageous.
- Experience in Medical Device Design and Development processes
- Experience in Risk Management processes.
- Experience of validating processes to medical device regulatory requirements
- Project management experience
- Knowledge of analytical and statistical techniques, including SPC and inspection and test methodologies
- The ability to develop and write protocols, validation reports and engineering reports
- Competent working knowledge of recognized Quality Management Systems (e.g. ISO13485),
- Awareness of relevant laws and regulations (e.g. IVDR/MDR/ FDA/ Canadian)
- Broad knowledge of engineering and technical applications applied in the development of medical devices.
Job Type: Full-time
- Quality Engineer: 2 years (Preferred)