Objective and main task of the function
Support site production, operations, maintenance, calibration and quality teams.
Serve as the quality representative during any product or process investigation and during external and internal audits.
Prepare, execute, review and lead validations, technical studies, test method validations and other studies/reports.
Lead various projects related to manufacturing activities.
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.
Tasks
Support site production, operations, maintenance, calibration and quality teams by addressing emergent issues that might arise due to the operation processes and during the implementation of new 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.
Lead, prepare, execute and review 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, review 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.
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).
Serve as Quality Management designee for assessment, release and approval of new and existing assets within Equipment Control, Maintenance and Calibration area.
Other duties as assigned.
Requirements and skills
Education: A Bachelor’s degree in quality, mechanical, life sciences or industrial engineering.
Special Knowledge: Solid understanding of quality system regulations applicable to the manufacture and global distribution of medical devices or drugs; solid understanding of investigation techniques including design of experiments and root cause analysis; understanding and application of Quality System Auditing and Analysis; solid grasp of basic statistical techniques with basic understanding of advanced techniques in data analysis; good 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; must be highly proficient in written and verbal communication.
Professional Experience: Minimum five years’ experience or advanced degree with three years of experience in quality engineering or equivalent position 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 packaging and sterilization required; experience in the vision care or intraocular lens industry preferred.
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