Quality Engineer II

17 hours ago

Galway, Ireland Pale Blue Dot® Recruitment Full time

Our Client, an exciting medical device start up in Galway City is hiring a Quality Engineer.

The successful candidate will support process quality and design assurance. The level of seniority can be tailored to the expertise of the suitable candidate.  Collaborating closely with R&D, Clinical, Regulatory, and Manufacturing Engineering teams, you will provide essential quality expertise for our clients products. Your role will also involve contributing to design considerations for manufacturing and assembly. Most importantly, you should enjoy working in a dynamic, fast-paced environment, be enthusiastic about engaging with people, and excel at taking ownership to deliver projects on time, ultimately making a meaningful impact on patients' lives

Responsibilities include but are not limited to the following:

  • Ensure smooth transition of activities from design to manufacturing e.g. transition of dFMEA to pFMEA, transition of Design Specifications to Manufacturing Specifications, transition of Design Test Methods to Process Test Methods, etc.

  • Support Design Verification and Design Validation testing and associated methods.

  • Together with the R&D team, plan & support builds for R&D testing, product verification, clinical trials and commercial use of patient-facing medical devices.

  • Lead the transfer of an assembly line for electromechanical medical device(s), with guidance from the Project Manager and Quality Director.

  • Support validation of equipment and processes as required.

  • Work with existing and future external manufacturing partners and suppliers.

  • Continually look for opportunities to optimize processes.

  • Engineering , scientific or technical degree (including ASQ CQE).

  • 3 years+ engineering experience working within a ISO 13485 QMS or equivalent environment.

  • Experience in Optimizing processes with a view to Design for Manufacturability (DFM).

  • Installing and validating new equipment / processes / test methods.

  • Problem solving & root cause investigations.

  • Technical Skills: Use of statistical tools and Proficient in MS Excel & MS Word.

  • Comfortable and confident communicating with internal and external stakeholders.

  • The ideal candidate will be : Creative: Enthusiastic problem solver with innovative ideas; Open: Embraces and shapes company culture; gives and receives constructive feedback positively; Communicative: Strong written and verbal communication; clearly articulates ideas with supporting evidence ; Self-Driven: Resourceful, independent, and proactive; prioritizes personal development ; Organized: Effectively prioritizes tasks and ensures timely completion; Team-Oriented: Thrives in multidisciplinary collaboration towards shared goal

Experience Advantages:

  • Lead Auditor Certification.

  • Experience in manufacturing, PCB/electromechanical components, or process validation.

  • Background in startups/SMEs, line transfers, or training others

This key early role at a fast-growing company offers the chance to shape impactful patient-facing products and gain insights into novel technology development. Our Client will provide a competitive salary, flexible benefits, comprehensive training, and opportunities for personal growth. You will enjoy flexible working hours, generous vacation allowances, and a focus on work-life balance.

Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacancies.

-Pale Blue Dot Recruitment - The Resource for the MedTech Workforce-

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