In this Staff Design Quality Engineer – Risk Management role, you will be a quality engineer responsible for performing risk management activities associated with Client's on-market in-vitro diagnostic (IVD) products ranging from Whole Genome Sequencing Platforms, Assays, Automation, and Software products in adherence to Client's Quality Management System processes. This role will collaborate deeply with product SMEs in product development, manufacturing, as well as with design quality engineering functions at Client. This role requires an intimate understanding of Product Risk Management in accordance with ISO 14971:2019, a highly disciplined approach to creating and maintaining risk documentation, as well as the ability to quickly grasp highly technical concepts associated with Client's Next Generation Sequencing product portfolio.
This role will report into Client's Development Quality organization.
Responsibilities:Execute remediation of assigned IVD Risk Documentation in accordance to Client's Risk Management process into Client's electronic Product Risk Management System. Collaborate with area-specific SMEs in Design, Process, Usability, and Software as required to review and approve updated risk documentation. Provide management with status updates on assigned responsibilities- escalating issues and proposing solutions as necessary.
Requirements:5+ years overall experience with 2-4+ years in quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic or Medical Device development and/or manufacturing preferred. Demonstrated experience in executing and managing the complexities of system and sub-system level risk management activities like Hazard Analysis and Failure Modes and Effect Analysis (FMEA) in accordance with ISO 14971. Exceptional computer skills (specifically tool navigation, data entry, and collaboration) using web-based applications like SAP, Siemens Teamcenter, Polarion, Confluence, Jira, Microsoft Office/Teams, etc. Demonstrated ability to accomplish goals while working across departments. Highly effective communication, facilitation, coaching, and negotiation skills. Adaptable to fast-paced, dynamic work environment with shifting demands.
Bachelors degree or higher in Engineering, Chemistry, Biochemistry or related disciplines.