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

TASKS

1.     Quality Assurance Activites

·         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 empolyess Lead, Assist, collaborate and partner with Operations, Shipping, Manufacturing and Customer Service Departments on various investigations nad projects carried out in house

·         Update and maintain the QMS Documentation as required, including creating and revising SOPs and WIs.

·         Other tasks as assigned

REQUIREMENTS AND SKILLS

     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