OBJECTIVE AND MAIN TASK OF THE FUNCTION
Ensure that Manufacturing activities are performed following appropriate procedures and trainings, with respect to EHS/GMP and QMS compliance while achieving budgeted quantities, yield, and cycle times.
TASKS
Organizational and Human resources tasks:
- On a weekly and daily basis, organize operator workload in accordance with budgeted quantities and priorities.
- Provide feedback to Manager on resource needs.
- Participate in hiring of new employees.
- Coordinate vacations and absences within the team.
- Complete performance review with support of the Manager and participate to salary increase processes.
- Serve as the back-up for other Manufacturing Leads when needed.
Manufacturing Operations
- Leading production activities from Hydration area following detailed Standard Operating Procedures (SOPs) and work instructions.
- Ensure backup of missing Operators of the area.
- Collaborate and communicate effectively with Manager on yield issues.
- Update Key Performance Indicators to identify improvement opportunities.
- Responsible for Inventory management (physical & ERP) in the area.
Quality and GMP Compliance
- Ensure the team’s adherence to GMP guidelines, including documentation of all activities in batch records, and/or MES system to maintain product traceability and compliance with regulatory standards.
- Maintain strict adherence to gowning procedure and other hygienic measures in controlled manufacturing area and/ or in ISO 7 clean room.
- Give meticulous attention to detail and compliance with quality control processes to ensure all products meet STAAR’s quality standards.
- Report any potential nonconformity to the Manufacturing Lead.
- Complete trainings to Quality Management System and other assigned trainings within the required timeframe and ensure appropriate training of Operators of the area.
Environmental Health and Safety (EHS)
- Ensure EHS policies and procedures are followed to maintain a safe working environment, including proper use of personal protective equipment (PPE).
- Maintain a clean and organized work area to prevent contamination and ensure compliance with controlled manufacturing area and/or ISO 7 clean room standards.
Continuous Improvement
- Collaborate with quality assurance, engineering, and maintenance teams to troubleshoot issues and optimize manufacturing processes.
REQUIREMENTS AND SKILLS
Education: No specific education required
Special Knowledge: Very good English skills
Very good German and/or French skills
Proficient in MS Office (Word, excel, etc.) as well as Skype and other communication tools
Personality: open minded, well organized, able to work in international teams, flexible and autonomous with high service level, good communication skills
Professional Experience: 5-10 years of working experience in a similar position with team management, ideally in medical device industry.