Quality director
Core
Lead the quality control department to ensure all medical device products meet regulatory and corporate standards.
Role type
Senior leadership quality director
Builds
Medical device products compliant with international standards
Domain
Medical devices / Regulatory compliance
Required skills
Medical device regulations (ISO 13485, CFR Part 820), regulatory audits (FDA, EMA), quality system management, technical documentation, team leadership
Preferred skills
Biomedical engineering background, performance indicator development
Technologies
ISO 13485, CFR Part 820
Responsibilities
Define and implement quality strategies aligned with industry regulations, manage relationships with regulatory authorities, supervise internal and external audits, develop and monitor quality performance indicators, manage and develop the quality team
Seniority
Senior, hands-on IC