**Quality Engineer II Job Description**
About Us:
A leading Medical Device company in Tipperary seeks a Quality Engineer to support manufacturing and ensure high product quality standards.
Responsibilities:
* Investigate and resolve manufacturing issues with teams to identify root causes and implement corrective actions.
* Collaborate with the product development team to create product specifications, quality documentation, and quality plans.
* Contribute to risk analyses and Failure Mode Effects Analyses (FMEAs).
* Develop and optimize process monitoring systems by identifying critical process steps and applying techniques to minimize variation and prevent defects.
* Lead process improvement initiatives by identifying ways to capture key quality data and performing analysis to support product design and new product development.
* Assist in creating new quality tools and training materials to improve existing resources and their effectiveness.
* Evaluate system, process, and operation compliance with regulations and company standards.
* Serve as an internal auditor for Business System Certification (BSC) quality systems related to development and manufacturing.
* Approve the final Process Monitor Release for products before distribution.
* Demonstrate a strong commitment to patient safety and product quality by adhering to the Quality Policy and all related quality processes and procedures.
Requirements:
* Bachelor's degree Level 8 (or equivalent) in Engineering, Quality, Science, or a related field.
* Minimum of 2 years experience in the medical device industry or a similar sector.
Skills:
* Quality Assurance
* GMP Manufacturing Process