Senior Design Quality Engineer

This person will support a project. The individual will oversee a product project from start to finish and will be solely responsible for quality assurance. They MUST have DESIGN CONTROL experience within Research & Development (R&D). Candidates from QA manufacturing will be considered ONLY if they have previously held a technical role within R&D. Knowledge of chemistry is a plus.

Must Have

• 5/8 years of experience in roles
• Experience within Quality Assurance for medical devices in R&D including
• Validation, Design and Risk Management (see details below) Design Control
• Experience in project management
• Independent and accountable, able to work on project, efficient communication
• Available to work from Galway, flexible to go on site for urgency

Nice to have

• Chemistry/ formulation for this project

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Notes from the hiring manager at J&J

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 support the redesign of a commercial product for US, China and Japan markets.

Details need it

• 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.

JOB DESCRIPTION

• 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).

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.