Are you a seasoned Medical Device Quality Systems leader with expertise in FDA QMSR, ISO 13485, Process Validation, and QMS remediation? This long-term remote contract offers the opportunity to lead Production & Process Controls across a major enterprise quality transformation initiative.Key ResponsibilitiesLead the Production & Process Controls (PPC) workstream for a large-scale QMS program.Provide technical leadership for Process Validation (IQ/OQ/PQ), Supplier Quality, Design Transfer, IMTE, Acceptance Activities, PFMEA, and Manufacturing Quality Systems.Review and approve SOPs, validation packages, gap assessments, and technical documentation.Ensure compliance with FDA QMSR, 21 CFR Part 820, ISO 13485:2016, and ISO 14971.Support FDA inspection readiness, regulatory remediation efforts, and enterprise quality initiatives.Mentor cross-functional engineering and quality teams while driving consistent quality practices.Qualifications18+ years in Medical Device Quality, Manufacturing, or Quality Systems.6+ years leading technical teams or enterprise remediation programs.Deep expertise in FDA QMSR, ISO 13485, Process Validation, Risk Management, and Manufacturing Quality Systems.Experience supporting FDA inspections, Warning Letters, Consent Decree remediation, or major QMS transformation programs is highly desirable.Experience with ETQ, Veeva, MasterControl, APQP, PPAP, SCAR, and Lean Six Sigma is a plus.
about 1 month ago