Quality Engineer (R&D)
Full Time Job Description
Smart Reactors is seeking a Quality Engineer to join our team in Parkmore, Galway, Ireland.
About Smart Reactors
Smart Reactors is headquartered in Galway, Ireland and provides medical device coating technologies.
We offer solutions to reduce thromboembolic complications while promoting Cell Proliferation & Healing in implant devices.
The Role
The Quality Engineer will support our R&D Department, implementing quality systems and procedures according to ISO 13485 requirements.
This position will collaborate closely with internal teams to ensure compliance and promote a culture of quality across the organization.
Key Responsibilities
* QMS Management: Responsible for upgrading and improving the QMS system.
* Quality Documentation: Draft, approve, and manage quality documentation, including procedures, protocols, and reports and records, ensuring compliance with customer specifications and industry standards in a timely manner.
* Lab Support: Plan and perform lab bench testing/coating, conduct engineering and competitor evaluations.
* Customer Interface: Maintain ongoing communication with customers to ensure all quality requirements are met, fostering strong relationships and understanding of customer needs.
* Cross-Department Collaboration: Interface daily with other departments to promote quality awareness and integrate quality initiatives throughout the organisation.
* Internal Audits/CAPA: Coordinate audits and Corrective Action Request (CAPA, SCAR).
Qualifications
Third Level qualification in Engineering/Quality/Science required.
A thorough working knowledge of quality systems (ISO 13485) essential.
A working knowledge of Statistics, SPS, and ideally the use of Minitab recommended.
Experience
2+ years industry experience working in a regulated medical device/manufacturing area required.
Good knowledge of FDA 21 CFR820 and international regulatory requirements.
Experience with data analysis tools (e.g., Excel, Minitab) and familiarity with relevant regulatory and quality standards (e.g., GMP, ISO) preferred.
Requirements
Excellent problem-solving abilities and critical thinking skills.
Strong written and verbal communication skills.
Ability to work independently and as part of a team in a fast-paced environment.
Good knowledge of statistical evaluation techniques.
Strong interpersonal skills and the ability to communicate well both verbally and in writing.
Location and Travel
On-site in Parkmore, Galway.
Occasional travel may be required for conferences, collaboration, or fieldwork.
Flexible work hours may be needed to meet project deadlines or accommodate time-sensitive experiments.
Benefits
Competitive salary.
Performance bonus.
Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.