Are you passionate about using cutting-edge technology to improve lives? As a Senior Quality Engineer at Gilero, you’ll play a crucial role in ensuring the quality of medical devices and combination products that make a difference in the lives and health of patients. You will be responsible for quality oversight of the design, development, and production of medical devices and combination products with a focus on systematic continuous improvement in the areas of risk mitigation, phase-appropriate design reviews, and qualification strategy implementation.
Join us in a collaborative and innovative environment where your contributions will make a real difference. You’ll work with multiple disciplines and clients across a variety of products to help shape the future of healthcare technology, ensuring products meet the highest standards and positively impact patient outcomes across the globe.

• Represent the quality function in product development projects providing direction for development and commercialization activities.
• Author design history file documents during the development process.
• Translate user input into measurable product requirements and specifications.
• Lead design verification and validation activities, including authoring test protocols and reports.
• Manage, trend, and continuously improve assigned quality system elements (CAPA,
• Complaints, Supplier Management, External Audits, etc.).
• Lead risk analysis assessments of medical devices.
• Maintain accurate and complete Design History Files, including regulatory submission documents.
• Facilitate manufacturing transfer, including preparation and execution of process validation (IQ/OQ/PQ) protocols, and development of production inspection plans.
• Investigate, disposition, and resolve nonconforming material events during product development, pre-production, and production phases.
• Author new or revised procedures, train team members, and release quality system procedures, as required.
• Lead internal and external audits.
• Lead supplier selection, qualification, and ongoing monitoring.
• Lead investigations to determine root cause and failure modes.
• Maintain quality records, summarize data, and report quality metrics to the organization.
• Execute quality event initiation, investigation, and closure for nonconformances, CAPA, change control, and complaints. Perform effectiveness checks.