· Support site production, operations, and quality teams
· Support site production, operations, and quality teams by addressing emergent issues that might arise due to the operation processes. Serve as the quality representative during product or process investigation. Lead investigations including root cause analysis and health risk assessment of the identified product or process nonconformities.
· Define requirements and assess impact on products related to Equipment Lifecycle (new equipment, transfers, repairs, planned and unplanned modifications).
· 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.
· Initiate and lead project teams on non-conformance investigations regarding component failures, finished goods failures. This includes but is not limited to performing risk analysis, determining root cause and recommending corrective action.
· Conduct internal audits and supplier audits (as a backup). 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).
· Interface with external auditors (Notified Body) during audits at the Nidau and Brügg sites; participate in the preparation and completion of corrective action plans as needed.
· Other duties as assigned.
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 two years’ experience or advanced degree with one year of experience in quality engineering 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 hydration, packaging, and sterilization required, experience in the vision care or intraocular lens industry preferred.