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Design Quality Engineer
| Reference: | RK4686 | Location: |
Galway |
| Qualification: | Degree | Experience: | 3-4 Years |
| Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
Design Quality Engineer
RK4686
Contract – 12 months
Galway
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties:
• Responsible for ensuring Design control and Risk Management activities, wherever they are performed comply with the requirements of the Design Control and Risk Management processes.
• Provides Quality support/guidance to R&D and Lifecycle Management projects leads/team members.
• Resolves project issues by working with team members, suppliers, and others as appropriate.
• Applies thorough, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues.
• Manages and maintains the records related to design control applicable to product development and design/manufacturing change projects.
• Contributes and participates in design review meetings.
• Provides input into the generation of risk management file documents; Risk Management Plan, dFMECA, pFMECA and associated reports.
• Provides input into development of protocols / reports supporting the Design control process.
• Provides input and review to protocols and reports for sterilization, biocompatibility and packaging validations.
• Co-ordinates the timely review and approval of all details in R&D batch sterilization records as meeting the requirements of the cycle validated and appropriate for the product.
• Co-ordinates the review and approval of production records and sterilization records of product manufactured during the design control process to facilitate timely approval of Design reports.
• Supports bench test activity as required.
• Supports the translation of the design requirements into manufacturing requirements.
• Ongoing monitoring of data from Quality Management systems and provision of immediate feedback to quality management on deviations or issues of concern.
• Administration and management of systems for CAPA, non-conformances and for supplier corrective actions.
• Leads and/or facilitates compliance and improvement activities associated with the Quality System (e.g. CAPA).
• Prepares data as applicable for use in management review.
• Supports internal/Supplier audits as applicable.
Experience and Education:
• Bachelors Degree in a technical field is preferred.
• 3 years’ experience in the medical device industry and/or IVD/pharmaceutical preferred
• Knowledge of the application of the principles, concepts and practices of design control, sterilization and Quality Assurance processes
If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or [email protected] for further information.
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