Senior Quality Engineer, Combo Product External Quality

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.

Qualifications :

• Bachelors degree preferably in Biology Chemistry or Engineering
• 6 years of overall experience in Manufacturing Quality or Engineering
• Good verbal and written communication skills.
• Good problem solving and analytical skills
• Good interpersonal relations / communications skills
• Good negotiation skills
• Knowledge of quality / compliance management as well as regulations and standards affecting API Bulk Drug or Finished goods manufacturing.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time