Senior Design Quality Engineer
Job Type: Full-time, Contract (12 months)
Location: Galway, Ireland (Hybrid setting)
Overview
CK QLS is recruiting a Senior Design Quality Engineer to support our clients team on a 12-month project with potential extension.
The role involves working in a hybrid setting, with 3 days on-site work per week in Galway, Ireland.
Key Responsibilities
* Ensure compliance with Design Control and Risk Management activities and processes.
* Direct Design Quality Engineers and Quality Engineers.
* Resolve project issues through collaboration with team members, suppliers, and other stakeholders.
* Manage and maintain records related to design control projects.
* Participate in design review meetings and generate risk management file documents.
* Develop and review protocols and reports for sterilization, biocompatibility, and packaging validations.
* Review and approve R&D batch details and production records.
* Monitor data from Quality Management systems and provide immediate feedback on deviations or issues.
* Lead or facilitate compliance and improvement activities (e.g., CAPA/non-conformance).
Requirements
* Minimum of a degree in a technical field.
* Minimum 5 years of experience in the medical device industry and/or IVD/pharmaceutical, with at least three years in a position with direct responsibility for QMS processes/sub-processes.
* Demonstrated knowledge of the application of principles, concepts, and practices of design control, risk management, sterilization, and Quality Assurance processes.
* Experience in preparation, participation, and response to external agency inspections (e.g., FDA and Notified Body Inspections).
* Thorough knowledge of Design Control requirements and processes.
* Thorough knowledge of Risk Management.
* Working knowledge of 21 CFR 820, ISO 13485 with familiarity of other foreign medical device quality system requirements.
* Ability to handle multiple projects simultaneously and discern major quality issues.
* Ability to work on own initiative and as a team player.
What You Will Gain
* Competitive salary ranging from 50,000 to 80,000 euros depending on experience.
* Opportunity to work on a high-impact project with potential for extension.
* Hybrid work setting with 3 days on-site in Galway, Ireland.
* Opportunity to support the redesign of a commercial product for global markets.