Director of Quality Operations (m/f/d) - Hybrid
Core
Oversee manufacturing control, quality control, quality engineering, and quality laboratory operations to ensure compliance with FDA, ISO, MDR, and other applicable regulations.
Role type
Director of Quality Operations
Builds
Medical devices for aortic disease treatment
Domain
Medical device manufacturing
Required skills
Quality management, FDA regulations, ISO 13485, process validation, audit management, regulatory inspections, change control, product lifecycle management, KPI monitoring, problem solving, error proofing, team leadership
Preferred skills
Cross-functional collaboration, stakeholder communication, process improvement, mentoring
Technologies
FDA regulations, ISO 13485, MDR
Responsibilities
Oversee manufacturing control, quality control, quality engineering, and quality laboratory operations; Lead qualification of equipment, verification and validation of processes, and change control activities; Ensure robust product lifecycle management; Establish and monitor key performance indicators; Drive effective problem solving, error proofing, and process improvements; Develop and mentor the sustain quality team; Collaborate cross-functionally; Serve as the primary point of contact for quality-related communications with internal stakeholders, regulatory authorities, and external customers
Seniority
Director, strategic leadership & operations