DELFI Diagnostics is hiring a
Design Quality Manager

Summary

Join our team as a Design Quality Lead and develop DELFI's programs from a Quality perspective. Provide leadership and guidance on design quality, risk management, change management, process validation, and equipment qualification. Manage a team of Quality professionals and support cross-functional teams.

Requirements

• BS Required (In Science, Engineering, or equivalent)
• 5+ years experience in Design Quality or directly-related field, in LDT and/or IVD or medical device industry
• Advanced working knowledge and experience in the application of FDA 21 CFR Part 820, ISO 13485, and ISO 14971 requirements
• Demonstrated strategic and tactical leadership building a high-performance results driven team
• Strong interpersonal and communication skills, including written and verbal communication, and presentation experience

Responsibilities

• Provide Design Quality leadership and guidance for product development (includes LDT and IVD), design control (e.g., design and development planning, design input, design output, design review, design verification, design validation, design transfer, product design changes, and design history file (DHF))
• Support the development teams in aligning our product development execution strategy with our Design Control and Risk Management procedures
• Review, approve, and audit Design History File (DHF) elements (e.g., plans, requirements, specifications, test protocols/reports, design traceability, and risk management documents)
• Lead the Change Management program for design changes and production and process changes
• Review and approve design control, risk management, product change management, production, verification/validation, equipment qualification documents per applicable regulatory requirements and company procedures
• Provide support for the preparation of pre-submissions, sprints, and PMA modules
• Train and mentor cross-functional peers and junior team members on best practices for maintaining compliance with the applicable Quality Management System (QMS) requirements and regulations
• Recruit, train, develop, and manage a team of Quality professionals to support the QMS from a Design Quality perspective
• Author, revise, review, and approve standard operating procedures and other controlled documents
• Support and lead Quality functional initiatives as well as Design Quality-related improvement activities
• Provide support and assistance to cross-functional teams to drive inspection readiness activities and support regulatory authority inspections
• Manage and lead the Design Quality activities to support DELFI’s product development and launch goals

Preferred Qualifications

• Previous experience in a regulated laboratory and product development environment for laboratory development test (LDT) and in-vitro diagnostics (IVD)
• Ability to influence, build, and foster relationships horizontally and vertically across the organization
• Ability to address and resolve a variety of complex issues diplomatically
• Molecular diagnostics background

Benefits

• $130,000 - $160,000 a year
• Compensation includes bonus, equity, medical/dental/vision