Engineering QMS Manager

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Full Time Chandler, AZ, US

3 days ago Requisition

Salary Range: $90,000.00 To $90,000.00 Annually

The Engineering QMS Manager is responsible for supporting Engineering Quality Management System (QMS) activities within a 503B sterile injectable manufacturing facility. The position supports the Engineering department in preparation, coordination, tracking, and maintenance of controlled documentation associated with deviations, CAPAs, change controls, preventive maintenance, calibration, equipment breakdowns, qualification activities, SOPs, engineering investigations, and other GMP-related Engineering records.

The individual will work closely with Engineering, Quality Assurance (QA), Production, QC/Microbiology, Validation, Warehouse, and other applicable departments to ensure Engineering QMS activities are completed accurately and within established timelines. This is a middle management position working under the guidance and technical oversight of experienced Engineering personnel.

• Support initiation, documentation, tracking, and closure of Engineering-related deviations, CAPAs, change controls, action items, and other QMS records.
• Assist Engineering personnel in collecting information required for deviation and investigation documentation.
• Maintain Engineering QMS trackers and follow up on approaching due dates.
• Coordinate with Engineering personnel to obtain supporting evidence required for QMS closure.
• Support preparation of Engineering responses to QA comments and document review observations.
• Assist with effectiveness-check documentation and CAPA follow-up, as applicable.
• Escalate overdue or potentially overdue Engineering QMS activities to Engineering management.

• Assist with collection and organization of information for Engineering investigations, including equipment history, alarm records, maintenance records, calibration history, logbooks, drawings, photographs, vendor reports, and other supporting documentation.
• Support preparation of investigation timelines and event chronologies.
• Assist Engineering SMEs with documentation of root-cause analysis using approved investigation tools such as 5-Why analysis.
• Support preparation of Engineering impact assessments under the direction of Engineering SMEs.
• Track investigation actions through completion.
• Ensure investigation attachments and supporting evidence are properly identified and maintained.

Final technical conclusions, root-cause determination, product-quality impact decisions, and QMS approvals remain the responsibility of qualified Engineering SMEs, Engineering management, QA, and other authorized personnel, as applicable.

• Support initiation and tracking of Engineering change controls associated with equipment, utilities, facilities, computerized/automation systems, and maintenance activities.
• Coordinate collection of supporting documents such as drawings, specifications, quotations, risk assessments, qualification documents, vendor documentation, and implementation evidence.
• Maintain implementation-action trackers and follow up with assigned action owners.
• Assist in compiling Engineering evidence required for change-control closure.

• Coordinate with the Operations and Maintenance (O&M) team at site to ensure timely execution of calibration activities, preventive maintenance (PM), facility maintenance, and maintenance of associated logbooks.
• Monitor compliance with scheduled maintenance and calibration activities and maintain effective communication with the O&M team regarding completion status.
• Escalate any deviations, delays, or instances where the O&M team is unable to complete assigned activities within the established timelines, in accordance with the defined escalation matrix.
• Maintain and periodically review Engineering preventive maintenance and calibration schedules.
• Track upcoming PM and calibration due dates and notify responsible personnel of activities approaching approved due dates/windows.
• Support reconciliation of completed PM/calibration records against the approved schedule.
• Assist in maintaining equipment and instrument master lists.
• Verify availability of completed work orders, calibration certificates, service reports, and associated documentation.
• Escalate missing, incomplete, or overdue PM/calibration activities to Engineering management.
• Support documentation associated with out-of-tolerance or overdue calibration events under SME supervision.

• Assist with preparation and revision of Engineering SOPs, preventive maintenance checklists, logbooks, forms, equipment records, and work instructions.
• Coordinate Engineering document reviews and incorporation of review comments.
• Support periodic review of Engineering SOPs and…