Quality Engineer II
About Your New Employer
This company is an early-stage medical device start-up focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease (ICAD). This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention.
Based in Galway, they are now seeking an experienced Quality Engineer with medical device experience to join them.
About Your New Job as a Quality Engineer:
* Lead compliance and improvement activities associated with the organization’s quality system (e.g., CAPA, audit programs, personnel training).
* Apply thorough, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
* Plan, execute, report, and follow up on quality system audits.
* Act as an audit escort and/or support coordination of backroom activities during inspections as required.
* Provide expertise in quality assurance, controls, and systems to support and develop the organization’s quality management system (QMS).
* Develop and implement control plans, inspection plans, and testing strategies to ensure product compliance with design and regulatory requirements.
* Work closely with suppliers to ensure robust quality agreements are in place, including periodic review of quality metrics.
* Provide ongoing support to internal teams in product development through first article inspection qualifications, test method development, and approval activities leading to commercialization.
* Gather and analyze data to support statistical rational sample testing requirements during early product development, ensuring compliance with product specifications, regulations, and internal requirements.
* Prepare and maintain detailed records of inspections, testing, and non-conformance reports.
* Collect, analyze, and report key data related to product testing, supplier performance, and internal quality metrics.
* Use data-driven insights to drive continuous improvement initiatives, ensuring optimal product quality and process efficiency.
* Develop test protocols or reports to support design validation and verification activities.
* Support quality control activities related to lot release of finished devices, received products, or other QC processes.
* Review and approve changes to products and processes for existing medical devices to ensure compliance with global regulations and internal procedures.
What Skills You Need:
* An NFQ Level 8 degree in quality engineering, life science, or related field.
* 3-5 years experience in a Quality Engineer role in the medical device sector essential.
* Quality certification and lead Auditor certification an advantage.
* Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation) and ISO 13485:2016.
* In-depth knowledge of quality engineering principles, methodologies, and tools (e.g., FMEA, SPC, Root Cause Analysis, CAPA, investigations etc.).
* Experience in the QA activities associated with the design and development of medical devices.
* Results and deadline driven with an ability to handle multiple tasks and operate in a fast-paced environment.
* Excellent interpersonal skills and ability to work with people to achieve results.
* Excellent written and communication skills, fluency in English, attention to detail, and strong technical writing skills.
Please note, you must have a valid visa and work permit for Ireland.
What's Next?
Click 'Apply Now' or for more information, please contact me at eward@sigmar.ie.
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