Senior Quality Engineer

Job Description

The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant.

Supports the Quality Engineering group by auditing commissioning and validation documentation completed by others, authoring and executing newly identified qualification/validation protocols, reviewing and approving critical planned maintenance routines, and other quality assurance tasks assigned by the MQA Section Manager and/or the Plant QA Manager.

• Implement and maintain the effectiveness of the Quality System.
• Ensure quality goals are met and practices comply with company policies and applicable regulations.
• Investigate plant events thoroughly, document findings, and submit reports to the CAPA system; perform product impact analyses and place product on QA hold as appropriate.
• Maintain effective liaison and cooperative relationships with other Quality areas and Plant departments.
• Participate on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approve standard operating procedures, ensuring compliance with policy.
• Approve calibration requests and ensure product/process limits are appropriate.
• Audit commissioning and validation documentation.
• Develop product quality plans, documents, and systems by creating specifications, risk analyses, and FMEAs; implement statistical quality programs and process monitoring systems.
• For U.S. manufacturing sites, perform batch release.

• 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 and communication skills.
• Knowledge of quality/compliance management and regulatory standards affecting API, Bulk Drug, or Finished Goods manufacturing.

$84,500 – $162,000 per year (range may vary based on location and experience).

Comprehensive package including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees; eligible for short‑term incentive programs.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, and serving our community. Equal Opportunity Employer/Veterans/Disabled.