Quality Engineer

2 weeks ago

Dublin, Dublin City, Ireland SRG Full time

This is a fantastic opportunity to play a key role in maintaining and enhancing quality systems within a regulated environment. You'll be at the forefront of ensuring compliance, driving continuous improvement, and supporting product development in a dynamic and collaborative setting.

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.
Who You'll Work With
  • Collaborate closely with the Quality Team to share knowledge and uphold standards.
  • Liaise with production teams to resolve quality issues and ensure smooth operations.
Decision-Making Scope
  • Make informed decisions on product quality issues flagged during production.
  • Escalate complex problems to senior quality leadership when necessary.
What You Bring
  • 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.
Why You'll Love This Role
  • 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.

Click below to apply.


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