The Senior Quality Engineer – Combination Products External Quality is responsible for the quality of assigned suppliers/contract manufacturers to ensure business objective are me with regards to on time delivery of product while assuring compliance to AbbVie requirements, applicable external regulations, and standards.   Products include injection molded components, and critical device components used to manufacture AbbVie On Body Injection Delivery Systems.  

Responsibilities:

• Support supplier quality development projects and continuous improvement activities.
• Investigate/coordinate supplier quality issues resolution with the appropriate department, including the dispositioning of non-conforming product, event, deviation, and market complaints. 
• Initiate and follow up on Supplier Corrective Action Requests (SCARs).
• Validate supplier corrective actions involving design and/or process changes to ensure they are robust, sustainable, and implemented for similar potential concerns across manufacturing lines and/or suppliers
• Coordinate supplier change notifications and ensure supplier changes are appropriately assessed for impact and change plans opened to mitigate any impact to AbbVie product / processes.
• Work with Product Development and Manufacturing/Process Engineers to develop appropriate receiving inspection test methods, sampling plans and acceptance criteria for new and existing components and materials, including first article inspection.
• Review and monitor strategic supplier performance, including providing trend analysis, investigation, and CAPA for monthly quality review.
• Liaise with internal customers to ensure effective problem resolution, develop metrics, develop reports, and identify supplier non-conformance trends.
• Develop and implement product quality plans, documents, and systems by creating product and quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.
• Assist management in implementing and maintaining a quality system that adheres to European, US, Canadian and other regulatory and Quality System requirements (ISO 13485, CFR 820 QSMR, EU MDR, and ISO 14971).
• Assist with internal Regulatory or Notified Body audits.
• Perform continuous improvement activities/projects to improve Product Quality, Compliance, and the Quality System.
• Establish and maintain relationships, including quality agreements with assigned suppliers/contract manufacturers.
• Plan, execute, and deliver projects effectively within defined time/cost parameters.
• Support supplier qualification activities for suppliers as needed.