Quality Manager (m/f/d)

at  Olympus Europa SE Co KG OEKG

Your responsibilities

• Support the implementation of European quality standards and guidelines, ensuring alignment with business requirements
• Manage external audits within the EMEA SBC region
• Communicate with external certification bodies
• Conduct quality management audits (ISO 9001:2015/ISO 13485:2016) across multiple sites in our European subsidiaries
• Analyze audit findings, identify key issues, and recommend best practices and improvements
• Moderate Root Cause Analysis sessions
• Oversee the status management of audit findings and timely completion of associated actions
• Provide support to European subsidiaries in regard to external audits

Your qualification

• University degree or equivalent qualification in a relevant field
• Proficient in ISO 9001 / ISO 13485 standards
• Knowledge of FDA 21 CFR Part 820 quality system requirements is a plus
• Familiarity with risk management principles is advantageous
• Fluent in English and German; additional language skills are a plus
• Excellent communication skills, with the ability to effectively communicate across all levels of the organization
• Strong interpersonal skills with the ability to develop and maintain productive working relationships in a team environment
• A business-driven attitude
• Willingness to travel as required (<25%)

Your benefits

• Flexible working hours, remote work possible (up to 60%)
• 30 days of holidays per year
• Modern office and an inspiring working environment
• Employee restaurant with live cooking and healthy food (subsidized)
• Public transport ticket (100 % subsidized) or free parking space
• Company sport groups and an inhouse company gym
• Employee Assistance Program to support your health, mental and emotional well-being
• A comprehensive company pension scheme
• Company medical officer and vaccination offers
• Childcare through our ‘Buttje&Deern’ partner
• Bike leasing

• Support the implementation of European quality standards and guidelines, ensuring alignment with business requirements
• Manage external audits within the EMEA SBC region
• Communicate with external certification bodies
• Conduct quality management audits (ISO 9001:2015/ISO 13485:2016) across multiple sites in our European subsidiaries
• Analyze audit findings, identify key issues, and recommend best practices and improvements
• Moderate Root Cause Analysis sessions
• Oversee the status management of audit findings and timely completion of associated actions
• Provide support to European subsidiaries in regard to external audit