Quality Engineer II

Job description

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. This Quality Engineer II is responsible for leading and executing Health Hazard Evaluations (HHEs) and supporting product Field Actions. The Quality Engineer II will work cross functionally with all manufacturing sites, design assurance, medical affairs and other SMEs involved in the HHE process. He/She will have e xposure and visibility to leadership on issues related to product quality, safety and/or performance is inherent with this role. A solid understanding of US and international regulations is required (21 CFR, MDSAP, EU MDR, etc.) ESSENTIAL DUTIES AND RESPONSIBILITIES: - Lead and coordinate all required activities, such as cross functional meetings, to support the completion of HHEs. - Ensure HHE documentation is complete, accurate and addresses regulatory requirements prior to approval. - Prepare H...