QA Manager

Role: Quality Assurance (QA) Manager within a medical device/software company, focusing on maintaining compliance with FDA, EU, ISO 13485:2016, and MDSAP standards. Primary objectives include overseeing Document Control, Training, Complaint Management, and Post-Market activities to ensure product safety, regulatory adherence, and quality system robustness. Responsibilities encompass developing, updating, and reviewing quality documentation; leading investigations into nonconformities; supporting audits; tracking QMS process performance; implementing process improvements; and participating in risk assessments. Qualifications: Bachelor's degree, at least 7 years of QA experience in regulated industries (Medical Devices or Pharmaceuticals), with a preference for SaMD experience; deep understanding of 21 CFR 820, ISO 13485, and MDSAP; proven leadership and cross-functional collaboration skills. Preferred skills include expertise in root cause analysis, process improvements, and navigating change in dynamic environments. High-value specifics: Medical Device/Software (SaMD) focus, QMS, regulatory compliance, audit readiness, risk management, and cross-functional stakeholder engagement. Work setup: U.S.-based, onsite/hybrid, with legal work authorization required.