- Reference: GY45895
- Job Type: Permanent
- Location: Galway
- Category: Engineering, Technical & Manufacturing
As Quality Engineer you will provide a support role to the Quality Manager in the routine maintenance of my client’s Quality Management Systems and in moderately complex Quality related projects. The Quality Engineer reports to the QA & RA Manager at AIL.
- 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:
- 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
- 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 spreadsheets.
For a confidential discussion and more information on the role/company please email your CV to: firstname.lastname@example.org