An international biotechnology company is advertising a vacancy for a Quality Engineer position in their Swiss office. The organisation is known for their work in manufacturing solutions and supplements for cataract surgeries and other ocular issues, including refractive surgery and glaucoma treatments. This is an exciting opportunity to work with a dynamic and innovative company that is rapidly changing the face of the eye healthcare industry.
- Support site production, operations, 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.
- Initiate and lead project teams on Corrective Action/Preventive Action (CAPA) projects.
- Assist Complaint Handling Department with technical / engineering support regarding customer complaints and product returns.
- 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 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.
- 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.
- 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).
- Assist Complaint Handling Department with technical/engineering support regarding customer complaints and product returns. Investigation may involve reviewing manufacturing batch records, vendor component records, non-conformity records, etc. to determine root cause of product failure.
- Interface with external auditors (Notified Body) during audits at company sites; participate in the preparation and completion of corrective action plans as needed.
Skills and Requirements:
- Bachelor degree in quality, mechanical or industrial engineering.
- 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 assembly, packaging, and sterilization required; experience in the vision care or intraocular lens industry preferred.
- Excellent 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.
- Demonstrated project management skills.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Josh Volpe at +44 203 800 1292 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.
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