- Reference: GY44646
- Job Type: Permanent
- Location: Galway
- Category: Engineering, Technical & Manufacturing
The Quality Engineer provides a support role to the Quality Manager in the routine maintenance of the company’s International’s Quality Management Systems and in moderately complex Quality related projects. The Quality Engineer reports to the QA & RA Manager.
- Possesses and applies a broad and increasing knowledge of Quality, and its application within the company to the completion of moderately complex assignments.
- Broad knowledge of the organization’s operations and practices to enable informed decisions in day to day operations and assignments.
- Applies problem-solving skills in order to deal creatively with complex situations, work that typically requires processing and interpreting, more complex, less clearly-defined issues. Identifies problems and possible solutions and takes appropriate action to resolve. Demonstrates skill in data analysis techniques by resolving missing/ incomplete information.
- Seeks consensus for decisions under conditions of uncertainty, sometimes with incomplete information, in order to produce effective end results. Applies risk assessment techniques in such circumstances.
- Drives business improvements through continuous improvement initiatives.
- Escalation point for quality related non-conformances and CAPAs.
- Drives compliance cross functionally in alignment with the regional objective for collaboration and multi-site ISO13485 certification.
Skills, Experience and Qualifications:
- Excellent interpersonal, written and verbal communication skills, including ability to make clear, well founded decisions regarding conformity during audits.
- Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
- Proficient with MS Word, Excel, Power Point, and management of spread sheets.
- Third level qualification.
- Minimum 5 years of experience in medical device industry with minimum 3 year of progressively responsible positions, including;
- competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP),
- awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL)
- Broad knowledge of engineering and technical applications applied in development of medical devices useful.
For a confidential discussion and more information on the role/company please email your CV to: email@example.com