Senior Design Quality Engineer - Medical Devices - Durham, NC in Durham

• Represent Quality in cross-functional development teams, providing direction for development through transfer to production activities.
• Author, maintain, and ensure compliance of Design History File documents during the development process in accordance with ISO 13485.
• Translate user needs, intended use, regulatory inputs, and risk controls into measurable product requirements, specifications, and acceptance criteria.
• Support design verification and validation activities, including statistical approach and analysis
• Support project related efforts with quality system elements (CAPA, Complaints, Supplier Management, External Audits, etc.).
• Participate in and facilitate risk management activities (hazard analysis, FMEAs, and risk assessments per ISO 14971)
• Ensure traceability and testability of design requirements and risk controls.
• Support manufacturing transfer, including review of 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 And pre-production phases; support production phases for transferred programs as needed.
• Act as technical expert (including potential author) for new or revised QMS procedures; May include train team members, and release quality system procedures, as required.
• Support internal and external audits (particularly for projects), as required with help of broader quality management team
• Support supplier selection, qualification, and ongoing monitoring with help of broader quality management team.
• Facilitate investigations to determine root cause and failure modes.
• Execute quality event initiation, investigation, and closure for nonconformances, CAPA, change control, and complaints as required.

• Able to work in the office at least 3 days a week
• Bachelor’s degree in engineering, science, or relevant field
• 5+ years relevant work experience
• Proficiency with FDA 820 CFRs/ISO 13485/cGMP quality management system and requirements for medical devices and/or combination product development and manufacturing
• Proficiency with ISO 14971 and application of risk management to the development of medical devices and/or combination products
• Experience with electromechanical medical devices and IEC 60601
• Strong preference for experience in pharma or medical device manufacturing and/or development environment; Strong preference for electromechanical systems based experience
• Experience using risk analysis and continuous improvement concepts
• Experience with GxP requirements
• Experience supporting audits
• Strong technical written and verbal communication skills
• Excellent interpersonal, change management, planning, and organizational skills
• Excellent oral, written, and presentation communication skills

Personal Attributes:

• Meets Gilero Core Values: Collaboration and Innovation of Excellence and Integrity
• Productive in a fast-paced, entrepreneurial environment.
• Commits to excellence and quality service to external and internal customers.
• Adheres to established policies and procedures, while contributing to continuous improvements.

Are you passionate about using cutting-edge technology to improve lives? As a Senior Design Quality Engineer at Gilero, A Sanner Company, you’ll play a crucial role in ensuring the quality development of new medical device and combination products; from ideation through transfer to manufacturing. You will be responsible for quality oversight of the design, development, and production of medical devices and combination products with a focus in the areas of risk mitigation, requirements definition, and verification and validation strategy and implementation.

Join us in a collaborative and innovative environment where your contributions will make a real difference on impacting the lives of patients and health care providers. You’ll work with multiple disciplines and clients across a wide 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.