Opportunity to join as the Quality Manager of a Software as a Medical Device organization with breakthrough AI technology who have an existing product portfolio, with more in the pipeline. Overseeing the compliant functioning of the Quality Management System (QMS) to industry Standards and FDA requirements specific to the domestic and international markets where the products are commercialized.
- Apply engineering, leadership, and Quality Assurance skills to effectively manage the QMS to industry Standards and FDA requirements in combination with utilizing the best industry practices for assuring the product safety and reliability.
- Manage the department functions, personnel and other resources to ensure that the Quality projects are sufficiently maintained with Quality Assurance representation
- Manage the day-to-day quality activities and ensure the QMS (i.e., complaint handling, incoming QA inspection, document control processing, etc.) is adequately resourced to maintain business continuity.
- Coordinate the performance of the Site Management Reviews and the Post-Market Surveillance Reviews.
- Oversee the Quality Training Program ensuring that employees are trained to the current SOP’s, work instructions, and safety requirements.
- Perform the Quality assessments and market strategies for new and existing products.
- At least 6 years' of experience working with QMS compliant to the FDA 21 CFR 820 and EU ISO:13485 guidelines
- Experience working in NPI and understanding how to incorporate newly cleared products into the existing QMS.
- Fully competent with all aspects of development and maintenance of the QMS, owning CAPA processes and carrying them out, deviations, SOP writing, audit readiness.
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.