Senior Quality Engineer

About the Position Werfen is a growing, family-owned, innovative company pioneering specialized diagnostics in Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Our global operations span over 30 countries, and we manufacture customized assays and biomaterials as part of our Original Equipment Manufacturing (OEM) line. We are looking for a Sr. Quality Assurance Engineer to apply engineering and quality principles to medical device and in‑vitro diagnostic products under EU and FDA regulations. The role focuses on risk management, design control, regulatory compliance, and cross‑functional collaboration. This position is not eligible for sponsorship for work authorization. Responsibilities Lead risk management initiatives throughout the product lifecycle in accordance with ISO14971 and related regulatory requirements. Manage and facilitate new risk assessments from initiation to completion, collaborating with key stakeholders to develop robust risk management plans. Collaborate at a systems level with R&D, Clinical, and other functions to identify risks, implement risk controls, and maintain a living risk management file. Review design and process changes, assess impacts, and ensure risk management requirements are satisfied. Support ongoing product compliance documentation and market authorizations by reviewing and responding to competent authority feedback. Assist teams in establishing product development requirements such as Design Input Documents, Design Verification/Validation, Risk Management and Usability requirements, CTQ identification, etc. Support the completion of DHF content, communicating regulatory compliance gaps. Serve as a Quality Core Team member on sustaining product lifecycle projects and new product development teams; represent Quality in manufacturing transfers and quality plan initiatives. Review and approve process and equipment validation (IQ, OQ, PQ) and software user acceptance testing. Qualifications Minimum 5 years of medical device experience in Quality or R&D Engineering, with risk management, design control, and product development experience. Experience in the IVD industry is preferred. Bachelor’s degree (BA/BS) from a four‑year college or university, or equivalent. BS in Engineering or a related scientific discipline is preferred. Quality certifications such as CQE, CQA, ASQ, or SSBB are preferred. Proficiency with Microsoft Office and electronic data file management. Extensive hands‑on experience with ISO14971, including implementation of risk management processes. Strong knowledge of risk management, CAPA, and Design Controls. Experience in systems engineering or connected system/software as a medical device (SaMD) is a plus. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact View email address on click.appcast.io for assistance. #J-18808-Ljbffr