Senior Design Quality Engineer
Contract – 12 months
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.
• 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.
• Provide Quality support/guidance to R&D projects leads/team members.
• Provide direction and support to Design Assurance engineers and Quality Engineers.
• Co-ordinate the Design Assurance Engineer resources to support business objectives.
• Resolve project issues by working with team members, suppliers, and others as appropriate.
• Apply thorough, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues.
• Contribute and participate in design review meetings.
• Provide input into the generation of risk management file documents; Risk Management Plan, dFMECA, pFMECA and associated reports.
• Provide input into development of protocols / reports supporting the Design control process.
• Provide input and review to protocols and reports for sterilization, biocompatibility and packaging validations.
• Co-ordination of 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-ordination of timely review and approval of production records and sterilization records of product manufactured during the design control process to facilitate timely approval of Design protocols and reports.
• Support bench test activity as required.
• Support 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 the systems for CAPA, non-conformances and for supplier corrective actions.
• Leads and/or facilitates compliance and improvement activities associated with the Neuravi quality system (e.g. CAPA).
• Act as an audit escort and/ or support coordination of backroom activity during inspections as
Experience and Education:
• Bachelors Degree in a technical field is preferred.
• 5 years of relevant work experience in the medical device industry and/or IVD/pharmaceutical
• Demonstrated 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 firstname.lastname@example.org for further information.