Quality Engineering Senior

QA&RA

Full-time Shift We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Quality Assurance Engineer will apply diversified knowledge of engineering, quality principles and practices for medical device products and in vitro diagnostic devices (EU and FDA).This individual will ensure that all system-level projects deliverables (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet quality and compliance requirements. Quality Assurance Engineer will have a strong Quality background and must be able to work in a team environment and be able to communicate clearly across all disciplines including Research & Development, Regulatory Affairs, Post Market Surveillance, Manufacturing Operations, Marketing, Validation, Manufacturing Technical Support and Regulatory Agencies. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time . Lead risk management initiatives for the entire product lifecycle in accordance with ISO14971 and related regulatory requirements. Assure applicable quality decisions are derived from the appropriate risk management document in accordance to the quality system. Independently manage and facilitate new risk assessments from initiation to completion working cross-functionally to develop risk management plans with key stakeholders that are robust and compliant with all procedural and regulatory requirements. Collaborate at a systems level with R&D, Clinical, and other key functions to identify risks, implement risk control measures, and document a robust and living risk management file. Review and provide feedback for changes to designs and processes and assess their impact to assure risk management requirements are met. Design Input Document, Design Verification and Validation requirements, Risk Management requirements, Usability requirements, CTQ Identification etc. Support DHF content completion, collaboratively communicating and resolving regulatory compliance gaps. Serve as a Quality Core Team member on sustaining product lifecycle project and new product development teams. Represent Quality for new and existing product improvement, manufacturing transfers, and quality plan initiatives. Assist in the QA review and approval of process and equipment validation / qualifications (IQ, OQ, PQ). Assist in QA review and approval of software user acceptance testing.

Minimum of 5 years medical device experience in Quality or R&D Engineering position with risk management, design control and product development experience.
Bachelor's degree (BA/BS) from a four-year college or university; BS in Engineering or associated scientific discipline, preferred
Quality certification, such as CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor), or ASQ, and/or SSBB, preferred
Proficient in Microsoft Word, Excel, and managing electronic data files.
Extensive hands-on experience with the ISO 14971 standard with demonstrated experience in implementing a device risk management process based on the standard and/or executing a RM.
Strong working knowledge of risk management, CAPA, and Design Controls.
Some experience in systems engineering and/or device development including connected systems and software as a medical device (SaMD)
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