Quality Engineer I

JOB REQUIREMENTS: Description About us: For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems. Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team! Position Summary: This position is primarily responsible for monitoring and auditing the quality of all manufactured goods in a medical device industry. Will work to not only find defects, but also to find the cause of the defect and develop a solution. Interact with customers and suppliers in support of engineering projects. Key Responsibilities: Provide Quality Engineering support for engineering project development, or sustained manufacturing. Provide Quality Project Management support as needed for product transfers from development to validation. Validation System Owner responsible for the development and management of the validation master plan along with the validation determination. Develop and maintain Validation Standard Operating Procedures. Develop and maintain project Quality Plan for assigned projects. Develop protocols, perform statistical analyses, and write reports for validations and formal process development, which requires quality-engineering involvement such as DOEs. Support the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols to ensure compliance with the Quality System. Provide Quality Engineering support for manufacturing. CAPA (Corrective and Preventative Action) system owner responsible for the support of the corrective action system and procedures. Interact with customers and suppliers to resolve CAPA and complaint investigations and in support of manufacturing. Provide Quality Support for the disposition of material via NCR's. Provide Quality Project Management Support as needed for product transfers from validation to production. Vendor approval and maintain... For full info follow application link. Cirtec Medical Corporation considers everyone for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all its related companies fully endorse equal opportunity. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/119E5E64EEB64605