Quality Engineer
- Co Westmeath
- €50,000-55,000 per year
- Permanent
- Full-time
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This is a full time, permanent, onsite role. Monday to Friday on Days.Your Key Responsibilities
- Maintain and improve quality systems aligned with ISO 13485, ISO 9001, and applicable medical device regulations.
- Develop and revise SOPs and quality documentation.
- Conduct internal audits to ISO 13485 standards.
- Actively participate in customer and regulatory audits.
- Support new product development, including trials, sampling, and production runs.
- Monitor vendor performance, issue non-conformance reports (NCMRs), and implement controls to protect product integrity.
- Report on quality performance metrics and lead change control initiatives.
- Investigate and close validation deviations, non-conformances, and CAPAs.
- Assist in the creation and execution of validation protocols (IQ/OQ/PQ), including data analysis and test scripting.
- Collaborate closely with the Quality Team to share knowledge and uphold standards.
- Liaise with production teams to resolve quality issues and ensure smooth operations.
- Make informed decisions on product quality issues flagged during production.
- Escalate complex problems to senior quality leadership when necessary.
- Bachelor's degree in Science, Engineering, or a related field.
- Minimum of 3 years' experience as a Quality Engineer in an ISO 13485 regulated environment.
- Certified Internal Auditor to ISO 13485.
- Proven experience in equipment validation and statistical analysis.
- Strong interpersonal skills, attention to detail, and a proactive problem-solving mindset.
- Be part of a team that values precision, collaboration, and continuous improvement.
- Gain exposure to a wide range of quality assurance activities in a regulated industry.
- Develop your career in a supportive environment with opportunities for growth and learning.