Quality Assurance Engineer; limited

OBJECTIVE AND MAIN TASK OF THE FUNCTION

• Perform Supplier Control and Management Activities
• Prepare and execute various studies and reports within Quality filed of action
• Support the risk management process and associated documentation applicable to STAAR Surgical AG
• Initiate and lead project teams on Corrective Action/Preventive Action (CAPA) projects
• Perform QMS Continuous Improvement Activities
• Develop and Monitor Performance Metrics for manufacturing activities performed at STAAR Surgical AG
• Support and Assist Operations, Shipping, Manufacturing and Customer Service Departments
• Execute, Plan and Support Internal Audits
• Support External Audits (in the backroom and as SME / Auditee)
• Lead and complete various cross departmental projects within Quality field of action

1. Quality Assurance Activities

• Signature of Certificates of Conformity upon request by Customer Service
• Performance of Checks-outs for orders from Japan for lenses not registered in the Japanese Market
• Initiate and Lead project teams on Non-conformance investigations regarding Component Failures, Finished Goods Failures, and Product Returns. This includes but is not limited to performing Risk Analysis, determining Root Cause and recommending Corrective Action
• Execution, Planning, Support and Response to Internal Quality System Audits
• Support External Quality System Audits as Auditee/SME and/or in Backroom Coordination
• Performance of Supplier Qualification and Management Activities, including initial qualification, monitoring, handling of SCRs and Supplier Audits
• Continuous improvement of Supplier Qualification and Management and Incoming Material Inspection Processes
• Record Maintenance Activities
• Support Environmental Monitoring and Pest Control Processes
• Participation and Moderation of QA / CA Meetings
• Preparation and Review of Internal Reports
• Perform Quality Trainings to STAAR employees Lead, Assist, collaborate and partner with Operations, Shipping, Manufacturing and Customer Service Departments on various investigations and projects carried out in house
• Update and maintain the QMS Documentation as required, including creating and revising SOPs and WIs.
• Other tasks as assigned

Education:

Bachelor’s degree in Engineering or Life Sciences preferred

Special Knowledge:
Strong English skills, both written and spoken

French and/or German, both written and spoken

Good IT knowledge in MS office

Personality:
Excellent organization and communication skills

Flexible and adaptable to change with ability to work under pressure

Responsible, operate with integrity and teamwork

Learning attitude and logical approach

Professional

Experience:

At least 4 years of experience in Quality Assurance within Medical Device and/or Pharmaceutical fields is required