Quality Engineer

General Description:

This position reports to the Quality Systems Manager. The Quality Engineer performs inspections and investigates deviations from current quality practices. Assists in developing quality control policies and evaluates production limitations. The candidate should have a good understanding of cGMP requirements. The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, quality control, attention to detail, and excellent communication with other functional areas and sites.

Essential Functions:

This description is intended to be illustrative of the major duties performed by the employee assigned to this position.

• Lead investigations for quality events, deviations and complaints
• Review and assist with implementation of changes through the change control process.
• Lead and assist with internal audits through the internal audit program.
• Assist with regulatory inspections and serve as Subject Matter Expert (SME) related to quality systems including deviations, CAPAs, change controls, etc.
• Implementing methods to inspect, test and evaluate the reliability of the manufacturing processes, products, and product equipment
• Prepare and deliver on time investigation reports by collecting, analyzing, and summarizing data
• Serve as Subject Matter Expert (SME) and ensure compliance with integrity of BMRAM system staying current with quality reviews and improving timeliness of equipment calibration.
• Provide quality guidance, expertise, and services in collaboration with all departments to ensure decisions for processes, data and product are quality driven, compliant to batch records, operating procedures, and regulatory requirements.
• Engage in cross-functional team discussions for issue resolution, process improvements and/or triage and initiate event records.
• Partner with peers to ensure alignment on issue resolution, decisions for processes, and compliance to batch records.