In this role, you will lead and develop DELFI’s Design Quality, Risk Management, Change Management, Process Validation, and Equipment Qualification programs from a Quality perspective. You will provide Quality oversight and guidance to ensure compliance and effective processes are maintained, per applicable regulatory requirements and company procedures.
What you’ll do
- 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)), risk management, change management, process validation/controls, and equipment qualification.
- 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.
What you’ll have accomplished 12 months from now
- Manage and lead the Design Quality activities to support DELFI’s product development and launch goals.
- Participated in the implementation and maintenance of the QMS from a Design Quality perspective that is compliant to FDA, CLIA, CAP, NY, and ISO requirements
- Support and partner with cross-functional teams responsible for implementation of new products, process improvements, and troubleshooting activities.
What you’ll bring to DELFI
- Required
- 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.
- Preferred
- 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.
