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
-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