Quality Assurance Lead - Medical Device R&D
QA Lead - Redesign Project QA Lead for a redesign project with one of our esteemed clients, a global leader in the medical devices industry. Our client’s innovation center in Galway, which specializes in stroke solutions, is hiring for a product redesign project aimed at the US and Japan markets.
The selected candidate will be the sole QA person for this project. This role will support the design team but will not directly engage in design work. Instead, the focus will be on quality assurance, validation, and risk management at the project level.
You will be solely responsible to manage a global complex project within a global player in the industry.
Job Description
Key Responsibilities
Ensure compliance with Design Control and Risk Management activities and processes.
Manage and complete Quality deliverables for R&D projects.
Provide Quality support and guidance to R&D project leads and team members.
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.
Review and approve R&D batch details and production records.
Monitor data from Quality Management systems, provide immediate feedback on deviations or issues.
Lead or facilitate compliance and improvement activities (e.g., CAPA/non-conformance).
Required 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.
Must Have
5/8 years of experience in similar roles.
Experience within Quality Assurance for medical devices in R&D, including Validation, Design Control, and Risk Management.
Experience in project management.
Independent and accountable, able to work on the project, and efficient communication.
Available to work from Galway and flexible to go on-site for urgent matters.
Nice to Have
Knowledge of chemistry/formulation for the project.
Notes from the hiring manager
The selected candidate will be the sole QA person for this project. This role will support the design team but will not directly engage in design work. Instead, the focus will be on quality assurance, validation, and risk management at the project level. This project supports the redesign of a commercial product for the US, China, and Japan markets.
Complete required details
Experience with Validation, including method validation and test validation.
Experience with Design Phase in design control and design quality.
Experience with Risk Management, familiar with RA standards for QA (any region).
Experience running a project, not only remediating.
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