• Assist with the running of the CAPA system including creating summaries, minuting meetings and contributing to root cause analysis determination
• Perform Internal Audit, assist in the management of audit scheduling and updates on all related actions.
• Assist and where appropriate lead in the compilation and execution of validation protocols for new product/processes and software. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and materiel. Manage QA related change control for specific projects as directed.
• Be responsible for the introduction and correct use of statistical QA methods into the production environment, and provide technical resource for production team on relevant IQ/OQ/PQ protocol issues.
• Assist with the maintenance of the Master Validation Plan and Critical System Changes for validated systems.
• Review and identify potential improvements with the Leeds Quality System and products to better meet regulatory requirements.
• Document and maintain in good order all relevant Quality assurance sections of Device Development History File and DMR as directed.
• Co-ordinate product/technology transfer between facilities from a QA perspective. Develop and utilize DFMEA/PFMEA and other QA risk analysis techniques in order to minimize potential risk during development/implementation activity.
• Ensure compliance with all Documented Quality system, FDA QSR’s and ISO 9001 requirements during day to day and assigned audit/CAPA activities.
• Must have experience and awareness of quality systems and techniques such as ISO9001 and SPC.
• Must have an engineering background in manufacturing, with a proven ability to interpret and create engineering specifications and procedures
• Must be PC literate, and familiar with MS Office applications.
• Must have a good understanding of engineering drawings and geometric Tolerating.
• Well developed organizational skills, with ability to work on own initiative. Good communication and presentation skills in order to effectively communicate technical and QA requirements to all functional departments and external facilities.
• Determined approach to problem solving, and ability to make appropriate decisions concerning product/process disposition and general Quality assurance procedural suitability.
• Ability to deal with flexible workload and type is essential, and also an ability to work productively within a project
• Self-motivated and self-disciplined, must be able to work unsupervised
- DIN EN ISO 9001
- FDA QSR
- QA (Quality Assurance)
- Fluent English, Fluent German
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