Senior Design Quality Engineer

Senior Design Quality Engineer Overview:

CK QLS are recruiting a Senior Design Quality Engineer, to join our clients team for a 12-month project with potential extension. The role will be based in a hybrid setting in Galway, Ireland, with 3 days on-site work per week. The ideal candidate will have 5-8 years of experience in Quality Assurance for medical devices in R&D, including validation, design, and risk management. The selected candidate will be the sole QA person for this project, supporting the redesign of a commercial product for US, China, and Japan markets.

Responsibilities:

• Ensure compliance with Design Control and Risk Management activities and processes, managing and completing Quality deliverables for R&D projects.
• Provide Quality support and guidance to R&D project leads and team members, and direct Design Quality Engineers and Quality Engineers.
• Resolve project issues through collaboration with team members, suppliers, and other stakeholders, applying systematic problem-solving methodologies.
• 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, as well as review and approve R&D batch details and production records.
• Monitor data from Quality Management systems, provide immediate feedback on deviations or issues, and lead or facilitate compliance and improvement activities (e.g., CAPA/non-conformance).

Qualifications:

• Minimum of a degree in a technical field is preferred.
• 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.

Day-to-day:

The selected candidate will be responsible for managing and completing Quality deliverables for R&D projects, providing support and guidance to R&D project leads and team members, and collaborating with stakeholders to resolve project issues. Additionally, the candidate will develop and review protocols and reports for validations, maintain records related to design control projects, and monitor data from Quality Management systems.

Benefits:

• 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.

If you meet the requirements and are looking for an exciting opportunity in the medical device industry, we encourage you to apply for this position.

Apply:

Please quote job reference 110 997 in all correspondence.