Senior Quality Manager
Core
Strategic and operational leadership for Quality Systems and Quality Engineering supporting Micro Reagents manufacturing operations.
Role type
Senior Manager, Quality Engineering (Manufacturing)
Builds
Safe, effective, and compliant medical device products
Domain
Life Sciences / Medical Device Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management System (QMS) design and implementation, FDA QMSR compliance, ISO 13485:2016 and MDSAP regulatory standards, audit leadership (internal/external/customer/regulatory), CAPA process management, strategic quality planning, budget management, team leadership and talent development, cross-functional stakeholder influence
Preferred skills
Medical device manufacturing experience, FDA inspection support, site-wide quality initiative leadership, Lean Manufacturing, Operational Excellence, ASQ certification
Technologies
QMS software platforms, regulatory compliance frameworks
Responsibilities
Lead Quality Systems and Quality Engineering activities for Micro Reagents manufacturing; Develop and maintain QMS procedures ensuring compliance with FDA, ISO 13485, and MDSAP; Lead and support audits and inspections; Manage departmental budgets, schedules, and performance metrics; Lead, coach, and develop Quality Engineering managers and professionals; Partner with Manufacturing, Engineering, and Regulatory Affairs to establish quality strategies
Seniority
Senior, hands-on IC with leadership responsibilities
