Manager, Quality Systems
Core
Provide strategic leadership for the site's Quality Management System to ensure compliance with global regulatory requirements and industry standards.
Role type
Manager, Quality Systems
Builds
Safe, effective medical devices and life sciences products
Domain
Medical device manufacturing / Life sciences
Required skills
Quality Management Systems (QMS), FDA 21 CFR Part 820, ISO 13485, CAPA, internal audits, document control, training programs, nonconformance management, regulatory inspections, cross-functional stakeholder influence, continuous improvement, team leadership, risk mitigation
Preferred skills
Certified Lead Auditor, risk management methodologies, process validation, quality remediation, sterile/non-sterile product manufacturing, FDA/ANVISA/BSI/DQS/GMED inspection preparation, analytical capabilities, change leadership
Technologies
FDA 21 CFR Part 820, ISO 13485
Responsibilities
Lead continuous improvement of the Quality Management System; Drive quality objectives and KPIs; Champion quality culture through coaching; Oversee quality system processes (CAPA, audits, document control); Lead interactions during regulatory and customer audits; Partner with cross-functional teams on new product introductions and validation; Develop and lead a high-performing team
Seniority
Manager, people leadership
