Hybrid Quality Manager – Operations

at Sanner Group

• Job title: Quality Manager – Operations
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Bensheim, Germany

About the role

• Quality Manager ensuring ISO 13485 compliance at healthcare company. Responsible for quality management processes, audits, and training in operations.

Responsibilities

• Ensure compliance with quality standards (ISO 13485, GMP, medical device regulations) in collaboration with Operations
• Manage deviation, CAPA and complaint processes, including root cause analysis and effectiveness checks
• Conduct and support internal audits and assist with external audits and inspections
• Approve serial line releases in coordination with Quality & Regulatory
• Implement production-relevant changes as part of change control management
• Provide technical guidance and coaching to the "Quality on the Shopfloor" team
• Plan, organize and deliver training on quality topics for production staff
• Actively contribute to new projects and continuous process optimization

Requirements

• Successfully completed technical or scientific degree or equivalent vocational training with several years of professional experience
• Several years of hands-on experience in quality management/operations, ideally in the medical device or pharmaceutical industry or primary packaging production
• Solid knowledge of relevant standards and regulations (ISO 13485, MDR/IVDR awareness, GMP)
• Practical experience with CAPA, FMEA and root cause analysis methods, as well as change control
• Hands-on experience leading and motivating cross-functional teams
• Analytical thinking and experience with quality metrics
• Very good German and good English skills, both written and spoken

Benefits

• 30 days of vacation
• Flexible working hours
• Option for remote/mobile work
• Diverse health and wellness offerings
• Bike leasing