Job Description
Our client, a leading multinational company based in Galway, is seeking to hire three Quality Engineers for an initial 12-month contract.
The Role
The Quality Engineer provides support to the Quality Manager in maintaining the Quality Management Systems and working on moderately complex quality-related projects.
Responsibilities
* Apply in-depth knowledge of quality principles to complete moderately complex assignments.
* Broad knowledge of operations and practices to enable informed decisions in day-to-day activities.
* Use problem-solving skills to deal with complex situations, requiring processing and interpreting more complex, less clearly defined issues.
* Identify problems and potential solutions, taking appropriate action to resolve them.
* Analyze data to resolve missing or incomplete information.
* Seek consensus for decisions made under uncertainty, sometimes with incomplete information, to produce effective outcomes.
* Apply risk assessment techniques in such circumstances.
* Promote business improvements through continuous improvement initiatives.
* Act as an escalation point for quality-related non-conformances and CAPAs.
* Drive compliance cross-functionally, aligning with regional objectives for collaboration and multi-site ISO13485 certification.
Requirements
* Third-level qualification.
* Minimum 5 years of experience in the medical device industry, with at least 3 years of progressively responsible positions.
* 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 the development of medical devices.
* Excellent interpersonal, written, and verbal communication skills.
* Ability to make clear, well-founded decisions regarding conformity during audits.
* Pro-active attitude, excellent organizational skills, and ability to manage multiple projects while delivering results on time.
* Proficient with MS Word, Excel, PowerPoint, and spreadsheet management.