QA Engineer
Dormont Manufacturing Company
- New Bremen, Ohio, United States
- New Bremen, Ohio, United States
About
As a Supplier Quality Engineer, you are accountable that our suppliers deliver quality parts, materials, and services according to company standards. You keep abreast of regulatory procedures and changes and interact with our suppliers and manufacturing to ensure compliance throughout the complete supply chain.
Main Responsibility
Ensures compliance requirements according to Medical Device Regulations ISO 13485, and the company quality manual
Ensures that suppliers deliver quality parts, materials, and services
Reviews and approves final product quality acceptance
Administrates and monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur
Generates analysis of the returns of non-conforming parts
Support the supplier evaluation to assess their overall performance and provides feedback in assessment of their operation
Supports and evaluate manufacturing issues with root cause analysis and corrective actions implementation
Ensures in close collaboration with manufacturing that all production processes are compliant
Qualifies suppliers according to company standards
Perform supplier audits
Requirements
Completed technical education with further training in the quality area
Experience in quality assurance and working with regulations
Used to working independently and communicative
Fluence in German, written and verbal, is mandatory, English is preferred
Experience in supplier auditing preferred
Min. 3 days per week onsite
As an equal opportunity employer, we welcome applications from individuals with disabilities.
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Languages
- English
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