· Plan and drive Switzerland specific validations, including equipment qualifications, process validations, room commissioning and routine validations linked to VMP.
· Support site production, operations, maintenance and quality teams
· Serve as the quality representative during any product or process investigation and during external and internal audits
· Prepare and execute validations, technical studies, test method validations and other studies / reports
· 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
· Act as a formal back-up for Quality Manager
· Lead and guide a team of Senior Quality Engineer, Quality Engineers and Quality Engineer Microbiology professionals to ensure the highest quality product and compliance with applicable regulatory and STAAR QMS requirements.
· Plan, execute and complete the required validations within STAAR Switzerland sites in order to meet the company’s projects timelines and ensure business continuity.
· Support site production, operations, maintenance and quality teams by addressing emergent issues that might arise due to the operation processes.
· Serve as the quality representative during any product or process investigation. Lead investigations including root cause analysis and health risk assessment of the identified product or process nonconformities.
· Prepare and execute validations, technical studies, test method validations and other studies / reports as required. This includes preparation of protocols, establishment of test methodology and acceptance criteria, training personnel, execution, data analysis, investigation, and writing final reports.
· Support the risk management process and associated documentation applicable to STAAR Surgical AG, ensuring that Risk Management Reports, Hazard assessments, etc. are generated or updated when required.
· 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 or initiate and follow up on the SCRs.
· Conduct internal audits and supplier audits. This includes preparation of audit plans, audit reports, and verifying corrective actions have been completed and are effective.
· Initiate and lead project teams on Corrective Action/Preventive Action (CAPA) projects. This includes, but is not limited to, performing risk analysis, root cause analysis; developing a corrective action plan, implementing the plan, and submitting a summary report for project closure and conduct effectively checks (EC).
· Host external audit as a back-up for Quality Manager, interface with external auditors (Notified Body) during audits at the STAAR Surgical AG; participate in the preparation for the external audit and in the completion of corrective action plans as needed.
· Serve as Quality Management Representative for assessment, release and approval of new or existing assets within Equipment Control, Maintenance and Calibration area
· Serve as Quality Management designee for assessment, release and approval of various QMS related documents and records (e.g. internal audits, supplier audits, NC, CAPA, risk management documentation)
· Other duties as assigned.
Education: A Master’s degree in scientific or engineering field
Special Knowledge: Understanding of quality system regulations applicable to the manufacture and global distribution of medical devices or drugs.
Understanding of investigation techniques including design of experiments and root cause analysis.
Understanding and application of Quality System Auditing and Analysis
Understanding of basic statistical techniques.
Proficient English skills, both written and spoken
French and/or German, both written and spoken
Project management, organization, writing skills required.
Demonstrated expert knowledge of Windows-based software, including Word, Excel, Access, Project, and Power Point.
Personality: Ability to influence and build consensus across cross-functional groups.
Proficient in written and verbal communication
Professional Experience: Minimum five years’ experience or university degree with 3 years of experience in leading quality engineering group in the medical device or pharmaceutical industries, including the practical application of FDA Quality System Regulation and ISO 13485 or equivalent. General knowledge of manufacturing processes such as injection molding, assembly, packaging, and sterilization required; experience in the vision care or intraocular lens industry preferred.