Quality Engineer
About Us
At Integer, we live by a set of core values that unite us and drive our success. Our values are embedded in every aspect of our work.
Our Values
We prioritize our customers' success and strive to create better solutions for them. We believe in the power of teamwork and collaboration to achieve common goals. We interact with each other respectfully, communicate openly and honestly, and uphold the highest standards of integrity in everything we do.
Job Summary
The Quality Engineer is responsible for maintaining and improving our quality systems and monitoring production processes to ensure compliance with established controls.
Key Responsibilities
* Ensure continued compliance with regulatory standards, including ISO 13485 & MDSAP, ISO 14000, and Quality Plans and Risk Management Documents.
* Monitor production processes and provide trend analysis, potential improvements, and areas for improvement to senior management.
* Review and propose changes to sampling plans based on trend analysis and system updates.
* Support Non-Conformance Report meetings and ensure internal and customer concerns are addressed.
* Review and approve critical documents, including Validations, Change Requests, Document Revisions, Non-Conformance Reports, Internal Audits, FMEA, and Deviation Requests.
* Attend project meetings and participate in daily cell meetings.
* Prepare information for KPI and Management Review meetings.
* Contribute to developing a world-class lean manufacturing system within the Integer New Ross team.
* Adhere to Integer's behavioural standards.
Requirements
To succeed as a Quality Engineer, you should have:
* A degree in engineering, science, or a quantitative field.
* Experience in analysis and reporting using tools like Minitab, Power BI, or equivalents.
* Rigorous attention to detail and strong technical report writing skills.
We're looking for individuals who can communicate effectively, lead when required, coordinate tasks, and possess knowledge of statistical and quality improvement methods.