Quality Engineer

4 weeks ago

Galway, Galway, Ireland Smart Reactors Service Limited Full time

Quality Engineer (R&D)

Full Time Job Description

Smart Reactors are currently seeking a Quality Engineer to join our team located in Parkmore, Galway, Ireland.

About Smart Reactors

Smart Reactors is headquartered in Galway, Ireland and is a trusted provider of medical device coating technologies. We provide solutions to reduce thromboembolic complications, while promoting Cell Proliferation & Healing in the case of implant devices. The company offers a wide range of services from early coating selection to manufacturing process transfer, while supporting regulatory approval & commercialisation.

Job Summary

The Quality Engineer will support our R&D Department, playing a vital role in implementing quality systems and procedures in-line with ISO 13485 requirements. This position will collaborate closely with internal teams ensuring compliance and promoting a culture of quality across the organization.

Key Responsibilities

  1. QMS Management: Responsible for the upgrade & improvements to the QMS system.
  2. Quality Documentation: Draft, approve, and manage quality documentation, including procedures, protocols, and reports and records, to ensure compliance with customer specifications and industry standards in a timely manner.
  3. Lab Support: Plan and perform lab bench testing/coating, conduct engineering and competitor evaluations. Plan, develop, coordinate, and execute study activities for new products and processes.
  4. Customer Interface: Maintain ongoing communication with customers to ensure all quality requirements are met, fostering strong relationships and understanding of customer needs.
  5. Cross-Department Collaboration: Interface daily with other departments to promote quality awareness and integrate quality initiatives throughout the organization.
  6. Internal Audits/CAPA: Coordinate audits and Corrective Action Request (CAPA, SCAR).

Qualifications

  1. Third Level qualification in Engineering/ Quality/ Science.
  2. A thorough working knowledge of quality systems (ISO 13485) is essential.
  3. A working knowledge of Statistics, SPS, and ideally the use of Minitab.
  4. Preferable Auditing experience to the requirements of ISO 13485/ 21 CRF Part 820.
  5. Proven experience in leading quality improvement initiatives and managing projects.

Experience

  1. 2+ years industry experience working in a regulated medical device/ manufacturing area.
  2. Good knowledge of FDA 21CFR820 and international regulatory requirements.
  3. Experience with data analysis tools (e.g., Excel, Minitab).
  4. Familiarity with relevant regulatory and quality standards (e.g., GMP, ISO).
  5. Excellent problem-solving abilities and critical thinking skills.
  6. Strong written and verbal communication skills.
  7. Ability to work independently and as part of a team in a fast-paced environment.
  8. Good knowledge of statistical evaluation techniques.
  9. Strong interpersonal skills and the ability to communicate well both verbally and in writing.

Location and Travel

On-site, 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 of Working with Smart Reactors

  1. Competitive salary.
  2. Performance bonus.

Equal Opportunity: 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.

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