OverviewWerfenThis is a hands-on role where the Sr. 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. This Sr. 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. If you have the required skills, don't wait, apply today!!
This position is not eligible for sponsorship for work authorization. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time .ResponsibilitiesKey Accountabilities:- 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.
- Support on-going product compliance technical documentation and on-going market authorizations through review and response to competent authority feedback in a timely manner.
- Support teams to establish product development requirements e.g., 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.
QualificationsMinimum Knowledge & Experience required for the position:- Minimum of 5 years medical device experience in Quality or R&D Engineering position with risk management, design control and product development experience.
- Experience in the IVD industry, preferred.
- Bachelor's degree (BA/BS) from a four-year college or university; or equivalent combination of education and experience.
- 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.
Additional requirements:- 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)
