Product Quality Specialist
Trice is looking for an experienced Product Quality Specialist to join our global team and take charge of our quality procedures related to customer needs, clinical evaluation and post-market surveillance. We are a small distributed team building the world’s best platform for doctors and patients to manage their medical images and communicate with each other. You will work with both regulatory and product teams to evolve our processes as well as ensure product releases and new features have all relevant customer and clinical documentation established.
- Responsible for the continuous improvement of the post market surveillance and customer feedback procedures.
- Leading global cross-functional discussions related to product feedback and roadmap prioritizations ensuring compliance and continual improvement.
- Contribute to the development of new features and products, supported by post market data and customer insights.
- Preparing material for Management Review meetings and Regulatory Submissions as requested.
- Maintaining MDR documents and updating Clinical Evaluation Reports and related materials
- Supporting the CAPA process and (when required) leading investigations associated with post market surveillance findings.
- Ensuring that procedures and practices are in compliance with global regulatory requirements.
- Responsible for performing tasks to support the quality system and quality policy as directed by Management.
- Occasional travel to partners, customers, and industry events is expected.
- Experience with clinical workflows and medical devices and/or EMR systems.
- Working Knowledge of ISO 13485 / ISO 14971 / FDA QSR Part 820 & 803 / Health Canada / MDD and EU MDR requirements related to complaints, reporting and post market surveillance, as well as clinical evaluation activities
- Excellent attention to detail
- Great communication skills and you are comfortable in front of customers
- Comfortable working in a remote team
- Proficient in English and one major European language.
How to Apply:
This position is open to EU residents. Email CV, cover letter, and any relevant material to the following email address email@example.com
For more information, go to www.triceimaging.com/company