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Job Description
The Quality Engineer will primarily be responsible for maintaining and improving quality systems, ensuring compliance with regulatory standards, ISO 13485 & MDSAP, and ISO 14000, and monitoring production process for quality product shipment. Main responsibilities:
- Ensure continued compliance with all Regulatory Standards, including ISO 13485 & MDSAP, and ISO 14000.
- Monitor production process for compliance to implemented process controls.
- Provide trend analysis of data from the controls and propose potential improvements for review with engineering.
- Review and propose changes to sampling plans based on trend analysis and changes to the system.
- Support NCR meetings to ensure internal and customer concerns are handled and dealt with in an appropriate manner.
- Review and ensure that area of responsibility documents are approved in an appropriate and timely manner.
- Ability to communicate and work with people inside and outside the department.
- Good communication and technical report writing skills.
- Rigorous attention to detail.
- Degree with strong engineering, science, or quantitative content.
- Experience in analysis and reporting using Minitab, Power BI, or equivalent.