Senior Quality Engineer

The Sr. Quality Engineer is responsible for the day-to-day management, oversight, and continuous improvement of Quality activities supporting pharmaceutical secondary packaging and medical devices contract manufacturing operations. This role ensures all quality related activities are executed in compliance with applicable FDA regulations, including 21 CFR Parts 210, 211, and 820, internal procedures, and customer requirements.

The Sr. Quality Engineer provides operational quality leadership for pharmaceutical packaging and medical devices contract manufacturing operations, including supervision and development of GMP Quality Associates/Specialists; oversight of batch record review and disposition; management of deviations, investigations, and CAPAs; and implementation of Quality Management System processes. This role supports Quality during customer audits and regulatory inspections and works cross-functionally with Manufacturing, Engineering, Warehouse, and Regulatory Affairs to ensure consistent GMP compliance.

• Provide day-to-day quality oversight for operations to ensure compliance with applicable FDA regulations, including 21 CFR Parts 210, 211, and 820, internal procedures, and customer requirements.
• Ensure packaging activities, inspections, and material release activities are performed in accordance with approved procedures, specifications, and the Quality Management System.
• Support and, when necessary, perform on‑floor quality oversight activities to maintain effective GMP control during operations.
• Assist with external Technical Visits as requested.

• Support review and approve executed packaging batch records for accuracy, completeness, and GMP compliance.
• Ensure all deviations, discrepancies, and investigations impacting batch disposition are adequately resolved prior to product release.
• Support material disposition decisions in accordance with approved procedures and quality system requirements.

• Own and manage deviation, nonconformance, and investigation processes.
• Lead root cause analysis and development, implementation, and effectiveness verification of corrective and preventive actions (CAPAs).
• Trend quality events and identify opportunities for continuous improvement.

• Supports Quality Management Representative during customer audits and regulatory inspections.
• Prepare audit materials, present quality systems and records, and support responses to audit observations in coordination with Quality leadership.
• Support internal audits and periodic quality system reviews as required.

• Implement and maintain quality system processes supporting operations, including documentation control, change management, training, and risk management activities.
• Drive continuous improvement initiatives to strengthen GMP compliance, documentation quality, and operational effectiveness.
• Monitor and report quality performance metrics related to operations.
• Directly supervise, train, and develop GMP Quality Associates.
• Ensure personnel are trained and qualified to perform assigned GMP quality activities.
• Provide coaching and performance feedback to support consistent quality execution.

• Partner with Manufacturing, Engineering, Warehouse, Regulatory Affairs, and other functional teams to resolve quality issues and support compliant operations.
• Support customer communications related to assigned quality matters.

• Bachelor’s degree in a scientific, technical, or quality-related discipline (e.g., Chemistry, Biology, Engineering, Quality Management) required; advanced degree preferred.
• Minimum 5–8 years of progressive quality and hands‑on experience in a regulated manufacturing environment, with demonstrated experience supporting pharmaceutical, pharmaceutical packaging or medical devices operations.
• Strong working knowledge of FDA cGMP requirements, including 21 CFR Parts 210, 211 and/or 820.
• Demonstrated experience reviewing and approving batch records,…