Quality Assurance Specialist
hace 2 meses
**_What Supplier Quality Engineering contributes to Cardinal Health_**
Developing and implementing quality policies, procedures, and processes is crucial to ensure products, services, and raw materials comply with regulatory standards and specifications.
Supplier Quality Engineering plays a vital role in managing suppliers for product, service, and raw materials, quality planning, evaluation, and control. This role works cross-functionally in the development and implementation of prevention-based methodologies used in designing, manufacturing, testing, and correction of products and services.
**_Job Summary_**
This position is responsible for administering the Supplier Quality Engineer area. In this role, you will guide and work on the professional development of the members of the area. Coordinate the Supplier Quality and Incoming Quality Activities and other relative areas. Evaluate the performance and effectiveness of the suppliers and their materials towards established requirements and develop a team approach for addressing any deficiencies.
Lead in the supplier change request and develop the adequate plan in coordination with the Engineering department. Identify, evaluate, and execute opportunities for continuous improvement consistently in Supplier and Incoming areas. Coordinate work assignments of department employees. Maintain documentation of department policies and procedures and ensure compliance with established certified standards, applicable regulations, and company policies.
**_Responsibilities_**
- Manage and report supplier audit program in line with ISO and/or FDA 21 CFR part 820/other regulations and company requirements, assuring the execution of it in a timely manner.
- Assure that the Supplier Corrective Action program is consistent in the handling of corrective actions by suppliers (closing on time/effective investigations) and the correct product disposition when applicable.
- Maintains supplier performance matrix according to the plant objectives, and reports performance to top management and the suppliers.
- Oversee supplier performance regarding components by quality and monitor the supplier performance.
- Administrate the inclusion of new suppliers to the GASL.
- Bring support to the Quality System according with all procedures applicable to the position.
- Participate in annual supplier forums.
- Maintain compliance to set Key Performance Indicators related with suppliers.
- Promote a culture of continuous improvement and cost reduction with existing and new suppliers.
- Conduct quick and efficient assessments of potential Supplier Quality systems, with limited information.
- Work with new and existing suppliers to develop, implement, and maintain technical quality assurance systems and activities, to include MSAs, SPC, Quality Plans, Control Plans, and FMEAs.
- Ensure proper approval and documentation practices are followed for any process, material, or tooling change (SCR - Supplier Change Request) at suppliers.
- Drive together with the Engineering department supplier events, changes, and new activities that require validations, CDPs, and any other requirement.
- Generates and maintains incoming inspections procedures.
- Provides technical support for the introduction of component from new supplier or updates in the current RMPS and analyzes incoming material defects.
- Perform deviation investigations into quality issues arising from supplier activities.
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