Quality Engineer II
About Your New Employer
This company is an early-stage medical device start-up company 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 on eward@sigmar.ie
