Position Overview
Our client, a dynamic start-up based in Galway, seeks an experienced Quality Engineer to contribute to their team. This role requires a proven track record in quality and regulatory control of medical devices.
The ideal candidate will have a strong background in quality engineering, test reporting, batch release, first article inspections (FAI), data collection for sample testing, and supplier qualification and evaluation processes.
Responsibilities
* Ensure compliance with company policies and procedures, as well as applicable national and international regulations.
* Lead compliance and improvement activities associated with the company's quality system (e.g., CAPA, audit programs, personnel training).
* Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
* Plan, execute, report, and follow up on quality system audits.
* Support internal teams in product development through first article inspection qualifications, test method development and approval activities, and commercialization.
* Analyze data to support statistical rational sample testing requirements during early product development and ensure compliance with product specifications, regulations, and internal requirements.
* Collect, analyze, and report key data related to product testing, supplier performance, and internal quality metrics.
* Develop test protocols or reports to support design validations and verification activities.
* Review and approval of changes to products and processes for existing medical device products conducted in compliance with global regulations and internal procedures.
Essential Skills / Experience/ Education
* A degree in quality engineering, life science, or a related field.
* 3-5 years of experience at a quality assurance role in the medical device sector, preferably in a FDA/MDR regulated environment.
* Quality certification and lead auditor certification are an advantage.
* In-depth knowledge of quality engineering principles, methodologies, and tools (e.g., FMEA, SPC, Root Cause Analysis, CAPA, investigations).
* Results-driven with excellent interpersonal skills, fluency in English, attention to detail, and strong technical writing skills.
* Proven ability to work effectively as part of a team and interact professionally with all organizational levels.
* Proficiency in MS Office products.