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Senior Design Quality Engineer

Vita Data Sciences
Galway, County Galway

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Job details

Full-time

Qualifications

Quality assurance

Full job description

Contract: 12 months with possible extension

Location: Galway, Ireland (On-site presence required: Full-time, with a flexible hybrid schedule (3 days on-site, 2 days remote)

Kelly FSP, on behalf of leading Medical Devices company, is looking for Senior Design Quality Engineer to provide QA technical and compliance expertise as part of teams tasked with establishing customer needs, developing new products, and/or modifying existing designs.

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 US, China and Japan markets.

DUTIES & 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).

REQUIRED QUALIFICATIONS:

- Minimum education of degree in a technical field is preferred.
- Minimum 5 years’ 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 the principles, concepts and practices of design control, 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.
- Working knowledge of 21 CFR 820, ISO13485 with familiarity of other foreign medical device quality system requirements.
- Ability to handle multiple projects simultaneously and to discern major quality issues.
- Ability to work well under deadlines and pressure.
- Ability to work on own initiative and as a team player.
- Ability to build good, strong and positive working relationships with cross functional teams internationally.
- Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience.

Apply today and start your fulfilling career!

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