Senior Supplier Quality Engineer

Responsibilities

• Monitor the performance of suppliers on a continuous basis and escalates any potential issues to supplier quality management.
• Supports the completion of supplier risk assessments and updates supplier quality database accordingly.
• Ensures supplier quality database is updated timely with any new information/addition, and ensures its accuracy, i.e. Supplier evaluation criteria are maintained, and supplier files are current.
• Compiles metrics for Supplier Quality Systems for internal stakeholders, tier boards and Quality System Management Review.
• Communicates supplier quality-related risks to LifeCell's business to management.
• Supports internal/regulatory audits on supplier quality related requests.
• Manages supplier nonconformity process, which includes but not limited to:
• Ensures all supplier related NCRs are processed/closed timely.
• Communicates supplier NCRs/SCARs to suppliers and necessary follow-up action are performed and documented timely per procedure requirements.
• Obtains necessary documentation required from supplier to support material release at LifeCell.
• Coordinates the review/approval of supplier NCRs/SCARs.
• Works with suppliers to ensure supplier investigations and CAPAs are robust and will drive to root cause.
• Ensures all supplier change notification records are created timely in Global TrackWise, and notifications for shared suppliers are communicated to Corporate Supplier management group timely.
• Assigns assessment actions to SMEs and works with cross functional SMEs and suppliers to complete the assessments timely.
• Provides feedback to suppliers in regard to change notifications and ensures necessary follow-up actions are completed as required.
• Follows up to ensure required internal changes resulted from supplier change notification are implemented timely.
• Coordinates the review/approval of supplier change notifications, ensures its timely closure and communicates the assessment result to suppliers as needed.
• Supports the team on completing supplier audits as required per process requirements.
• Bachelor's 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.
• Preferred:
• Bachelor's degree in Engineering is Desired
• 5 years' experience with Supplier Quality , Supplier Change Notification , Supplier Audits , New Supplier Qualification , and Risk-Based supplier management is Highly Desired
• Experience in Pharmaceutical or Medical Device industries is Highly Desired
• Additional Note:
• Willingness to travel domestically as needed, estimated to be 10% travel
• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• 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.
• 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
• US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
• https://www.abbvie.com/join-us/reasonable-accommodations.html

Benefits

Additional Information

We are seeking a Senior Supplier Quality Engineer to help strengthen our supplier quality systems and ensure the highest standards of compliance, reliability, and performance across our global supply base. In this role, you will partner with suppliers and cross-functional teams to proactively identify risks, resolve quality issues, and drive continuous improvement.

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