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 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
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
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