Job Summary
The Quality Engineer will primarily be responsible for maintaining and improving where necessary all quality systems and monitoring production process for compliance to implemented process controls.
Key Responsibilities
* Ensure continued compliance with all Regulatory Standards, including ISO 13485 & MDSAP, ISO 14000, Quality Plans, and Risk Management Documents.
* Monitor production process for compliance to implemented process controls, analyzing data trends and proposing improvements.
* Review and propose changes to sampling plans based on trend analysis and changes to the system.
* Ensure that in your absence, your area of responsibility is covered and other departments are informed of your arrangements.
* Support NCR meetings to handle internal and customer concerns.
* Review and ensure timely approval of documents, including Validations, Change Requests, Non Conformance Reports, Internal Audits, FMEA, and Deviation Requests.
* Attend project meetings and daily cell meetings.
* Prepare information for KPI and Management Review meetings.
* Comply with Integer behavioural standards.
Requirements
* Ability to communicate and work with people inside and outside the department.
* Good communication skills (written and oral).
* Ability to train and lead where required.
* Co-ordination, planning, and organisation skills.
* Knowledge of Statistical and Quality Improvement methods.
* Technical report writing skills.
* Rigorous attention to detail.
Education and Experience
Degree with strong engineering, science or quantitative content. Experience in analysis and reporting using Minitab, Power BI or equivalent would be an advantage. Education requirement can be substituted by strong experience as quality engineer or technician.