Quality Systems Engineer (R&D)
Full-time position at Smart Reactors, a trusted provider of medical device coating technologies.
Job Summary
The Quality Systems Engineer will support our R&D Department in managing and implementing ISO 13485 quality systems.
Key Responsibilities:
* QMS Management: Coordinate, upgrade, and maintain the ISO13485 QMS system.
* Quality Documentation: Manage quality documentation to ensure compliance with customer specifications and industry standards.
* Customer Interface: Maintain ongoing communication with customers to ensure all quality requirements are met.
* Cross-Department Collaboration: Promote quality awareness and integrate quality initiatives throughout the organization.
* Internal Audits/CAPA: Coordinate audits and Corrective Action Requests (CAPA, SCAR).
* Lab Support: Support lab bench testing/coating, conduct engineering and competitor evaluations.
Qualifications:
* Third Level qualification in Engineering/Quality/Science.
* Working knowledge of quality systems (ISO 13485) is essential.
* Working knowledge of Statistics, SPS, and ideally the use of Minitab.
* Preferable Auditing experience to the requirements of ISO 13485/21 CFR Part 820.
* Proven experience in leading quality improvement initiatives and managing projects.
* 2+ years of industry experience working in a regulated medical device/manufacturing area.
Location and Travel:
* On-site, Parkmore, Galway.
* Occasional travel may be required for conferences, collaboration, or fieldwork.
Benefits:
* Competitive salary.
* Performance bonus.
Equal Opportunity: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.