Supplier Quality Engineer

SUMMARY

The Supplier Quality Engineer is responsible for ongoing management of quality performance and oversight of quality issue resolutions for Suppliers.  Primary responsibilities include the evaluation and qualification of current and new suppliers, contractors and consultants on the basis of their ability to meet specified requirements, including regulatory, quality, safety and security requirements. This position enhances the current process to qualify and audit manufacturers, suppliers and contractors that meet business needs across the organization. In addition, this position will assist with the overall Supply Chain quality functions, including supplier corrective actions, root cause analysis, metrics/scorecards and overall supplier quality improvements. This role will also support the development and launch of new products.

Interaction with other functional areas:

R&D: Work with R&D personnel to facilitate material and supplier qualification for new product development projects and initiatives.

Purchasing: Ensure suppliers are aligned to meet quality standards and regulatory requirements and to facilitate timely resolution of quality.  Ongoing evaluation and performance monitoring of suppliers.

Production: Work with production and compounding regarding component and/or raw material defects and communicate with the supplier.

Responsibilities:

• Conduct supplier evaluation and risk assessments including on-site quality audits as required to ensure conformance to Supplier Quality System requirements. Work to identify and resolve potential problems and continually improve the process for qualification and evaluation of new and existing suppliers, specifications, components, and materials.
• Analyze audit results to develop, prioritize and execute corrective actions and supplier development action plans to continually improve supplier performance.
• Ensure closure of Supplier NC’s and CAPA’s, to confirm comprehension, development, and execution of corrective/preventive action with regards to any nonconformity cited.
• Develop supplier scorecard and metrics to improve quality of the product and process with measurable KPIs
• Provide supplier quality support on NPD and incoming purchased finished goods initiatives.
• Act as the key interface with site operations as it pertains to Supplier Quality Issues.
• Perform other duties as assigned

Basic Qualifications:

• Bachelor degree in science, math or related discipline
• 3-5 years experience in a regulated environment
• 2 years experience in supplier interfacing role
• Knowledge cGMP Guidelines and regulatory requirements.
• Detail oriented, and ability to work with others in a multidisciplinary team environment.
• Ability to travel independently (<5%)
• Strong time management / project management capabilities
• Strong analytical and written and oral communication skills
• Working knowledge of Process / Manufacturing applications

Reporting Structure:

This position reports to the Quality Manager.

Email us your resume today to hr@pharmacalway.com