Job Title: Quality Inspector – Documentation Control
We are seeking a highly skilled and detail-oriented Quality Inspector to join our team on a Specific Purpose contract for Maternity Leave cover. The successful candidate will be responsible for ensuring the quality of our medical devices, from initial design assessment to final product delivery.
Responsibilities:
* Approves incoming materials by confirming specifications, conducting visual and measurement tests, and rejecting unacceptable materials.
* Routine Final QA Product Inspections of finished parts in production by confirming specifications, conducting visual and measurement tests, and communicating non-conformances to Production Manager & Quality Dept.
* Routine Environmental Monitoring, including pressure differential readings, Particulate Monitoring, Microbial Monitoring.
* Documents inspection results by completing reports and logs and inputting data into quality database.
* Performs problem-solving and continuous improvement investigations.
* Conducts internal audits as required.
* Reviews and updates QA documentation.
* Provides assistance and support to the Quality Engineering and Operations function.
* Drives continuous improvement and best practices in QMS “Right First Time”.
* Maintains a safe and healthy work environment by following standards and procedures and complying with legal regulations.
* Updates job knowledge by participating in educational opportunities.
* Ensures compliance to all applicable regulatory standards and cGMP procedures and practices.
Requirements:
* Leaving Cert plus minimum 3-year Medical Device assembly experience.
* Proficient computer skills.
* Understanding of general principles of EN ISO 13485 & FDA 21 CFR 820.
* Competence in Inspection methods and reading drawings and specifications.
* Decision-making ability coupled with the ability to work on one’s own initiative and with minimum supervision is required, along with the ability to multitask and prioritize.
* Good interpersonal skills and organizational skills.
* Excellent attention to detail.
* Documentation skills.
* Competence in inspection methods and reading drawings and specifications.
* Understanding of the principles of product/parts and FIFO.
* Communicates any concerns about work process regarding environmental impact, health or safety issues to their manager.
This is a full-time, Specific Purpose contract for Maternity Leave cover. Estimated salary is approximately $60,000 - $80,000 per year, depending on qualifications and experience.