**Job Title**: Quality Manufacturing Engineer 2
Quality Manufacturing Engineer 2
**Overview**
Oversees the Quality Assurance in the processes related to the manufacturing of materials, components, sub-assemblies, and completed products and their supply chain, including compliance to regulatory requirements and/or procedures for regulated products/businesses. The processes include the introduction/validation of new/changed manufacturing processes and their associated Quality systems, the trend analysis and monitoring of manufacturing processes and their environment, the remediation to non-conformances, and the development and improvement of Quality systems.
**Responsibilities**
- Ensures that appropriate quality plans are made and a suitable quality system is in place, for both NPI's as well as for ongoing manufacturing that include all stages of the manufacture of the product/system and supports Quality System design.
- Validate risk analyses and risk mitigation plans and activities, control plans, and Quality Systems Oversee processes: trend analysis, assess impact and follow-up (e.g., in QS updates, control plans, competency upgrades, etc.).
- Review calibration plans and records, environmental controls, and training plans and records. Organize IQA audits, and execute internal audits for regulated products to assess the effectiveness of the QMS linked to production controls.
- Approve which processes need validation/re-validation after changes, and verify processes and plans/records.
**Requirements**:
- Bachelor's degree in engineering disciplines or related field or a combination of equivalent job experience in related field.
- 5 year of experience in Quality or Manufacturing or other related fields Desirable.
- Intermediate/advanced English
- Desirable ability to interpret technical drawings that may include mechanical dimensioning and Geometric Dimensioning and Tolerance (GD&T).
- Strong and proven knowledge of statistical methods and the use of standard quality tools (e.g. flowcharts, Pareto charts, cause and effect diagrams, control charts, regression analysis, etc).
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