Site Quality Lead / Staff Quality Engineer
Core
Strategic quality leadership for a site-based FDA-registered Specification Developer, ensuring compliant innovation and inspection readiness across the product lifecycle.
Role type
Staff Quality Engineer (Site Quality Lead)
Builds
Quality Management System, compliant product development, and inspection-ready state for clinical next-generation sequencing instruments.
Domain
Medical Device / IVD / Biotechnology / Pharmaceutical
Required skills
Quality Management System (QMS) ownership, Design Controls, Risk Management, CAPA, audit leadership, regulatory compliance (FDA/ISO 13485), cross-functional influence, strategic planning, continuous improvement.
Preferred skills
Complex instrument development, contract manufacturer management, APQP, PPAP, FMEA, MSA, SPC, ASQ CQE certification.
Technologies
ISO 13485, FDA QMSR, Design Controls, Risk Management methodologies
Responsibilities
Own the site's Quality Management System effectiveness and compliance; Serve as Management Representative leading Management Reviews; Provide strategic quality leadership from development to post-launch; Identify emerging risks and drive systemic improvements; Partner with cross-functional teams on supplier quality and manufacturing readiness; Execute continuous improvement of QMS processes (CAPA, deviations, change control); Represent the site during regulatory and customer inspections; Coach teams on quality best practices.
Seniority
Staff, strategic leadership with hands-on operational ownership
