Position Overview:

As the Quality Engineering Lead, you will partner with the cross-functional team to act as a champion of Design Assurance and Quality Engineering activities throughout the product development lifecycle. You hold your work and teams to the highest quality standards and ensure all applicable compliance standards and regulations are met. This is a hands-on role requiring deep experience in design controls, risk management, design verification and validation, and regulatory submissions. As a Quality Engineering lead, you will be building scalable quality systems while directly executing critical quality engineering activities. You will support multiple domains at the system level across hardware and software engineering, supplier quality and quality system implementation.

Primary Duties & Responsibilities:

• Lead and strategize ongoing implementation of the Quality Management System (QMS) in conformance with US FDA Quality System Regulations, ISO 13485, IEC 62304 and IEC 62366-1 and other relevant standards
• Provide quality oversight and support to the product development team in creation of design and development files (DDFs) including product requirements, software and hardware design specifications, design verification test protocols and reports, risk management file, cybersecurity risk files, biocompatibility and sterilization validation deliverables, traceability matrices, etc.
• Guide and lead risk management activities, including failure modes and effects analysis (FMEA) and hazards analysis, in alignment with ISO 14971
• Engage and collaborate with vendors and participate in assessing supplier qualifications
• Support and participate in internal and external audits, coordinating and providing documentation and evidence of compliance
• Lead root cause analysis for nonconformances, defects and CAPAs, issue management, management review and quality data analysis
• Mentor junior quality team members and provide quality leadership on projects
• Foster a collaborative environment, champion continuous improvement initiatives and promote a quality culture across the organization

Qualifications:

• Bachelor’s or Master’s degree in Engineering (e.g., Biomedical, Mechanical, Electrical, or related field).
• 10+ years of quality engineering or in medical device development from concept development to production release.
• Strong understanding of medical device regulations and standards (FDA, ISO 13485, IEC 62304, ISO 14971, IEC 62366-1) and experience working in a regulated environment
• Experience with software and hardware V&V activities, experience with AI/ML technology
• Hands-on experience with risk management tools (e.g. FMEA, risk analysis) and design controls
• Experience in establishing work relationships across multi-disciplinary teams and with partners in different time zones, building trust and demonstrating critical thinking
• Experience in navigating ambiguity, bringing clarity to complex situations and thriving in a fast-paced environment

Skills and Abilities:

• Proficient in working in eQMS tools with impeccable documentation skills
• Superior written and verbal communication skills to interface with cross-functional teams and regulatory bodies
• Strong analytical skills and excellent problem-solving skills
• Exceptional organizational skills and attention to detail