Senior Quality Systems Engineer

Job Summary

The Senior Quality Systems Engineer is a Senior-level Quality professional responsible for supporting, maintaining, and continuously improving the organization's Quality Management System (QMS) within a highly regulated pharmaceutical, medical device, or combination-product Contract Manufacturing Organization (CMO/CDMO). The position provides technical leadership for quality-system processes including CAPA, deviations, nonconformances, investigations, change control, risk management, audits, quality metrics, document control, training, supplier quality, and customer quality requirements. This role is particularly important in the CMO/CDMO environment because the organization may simultaneously support multiple customers, products, manufacturing processes, regulatory requirements, and Quality Agreements. The Senior Quality Systems Engineer serves as a key interface between Quality Assurance, Manufacturing, Engineering, QC, Regulatory Affairs, Supply Chain, Facilities, Maintenance, and customer Quality organizations and is expected to operate as a senior technical resource and quality leader without having direct reports.

Essential Functions

• Maintain and continuously improve the site's Quality Management System.
• Ensure QMS processes comply with applicable FDA, GMP/GxP, ISO, ICH, customer, and corporate requirements.
• Develop and revise Quality System procedures, work instructions, forms, templates, and    controlled documents.
• Lead Quality Management Review for the site and present results to upper management.
• Perform Annual Product Quality Reviews for each customer.
• Provide guidance on QMS requirements and promote a proactive quality culture.
• Lead the complete CAPA lifecycle from initiation through effectiveness, verification, and closure.
• Facilitate cross-functional CAPA investigations and evaluate root-cause analysis and action plans.
• Use structured methods such as 5-Why, Fishbone/Ishikawa, Fault Tree Analysis, Pareto analysis, and risk-based techniques.
• Lead investigations involving manufacturing deviations, process/equipment failures, laboratory events, material discrepancies, documentation errors, environmental excursions, product nonconformances, packaging/labeling issues, and data-integrity concerns.

• Perform product/process impact assessments and establish scientifically justified root causes and corrective actions.
• Evaluate recurrence and systemic impact across products, processes, and customers.
• Manage changes involving processes, equipment, facilities, utilities, computerized systems, materials, suppliers, methods, specifications, packaging, labeling, procedures, and validation.
• Conduct cross-functional assessments of quality, regulatory, validation, customer, and supply impacts.
• Ensure appropriate approvals and post-implementation effectiveness.
• Support internal, customer, regulatory, notified-body, ISO, and third-party audits.
• Serve as a Quality Systems subject-matter expert during audits and inspections.
• Lead and coordinate responses to findings, track commitments, and maintain inspection readiness.
• Participate in customer Quality meetings and support customer audits.
• Prepare customer-facing investigation reports, CAPA responses, and quality documentation.
• Balance customer requirements with site QMS requirements and regulatory compliance.
• Monitor KPIs for deviations, CAPAs, change controls, nonconformances, complaints, audits, suppliers, training, right-first time, and batch-first time performance.
• Identify adverse trends and systemic issues and present recommendations to management.
• Support effective document-control processes and controlled document review.
• Identify gaps between procedures and actual practices.
• Support and implement electronic QMS optimization and data-integrity compliance.
• Ensure records follow ALCOA principles.
• Monitor CAPA aging, overdue actions, recurrence, and effectiveness.
• Participate in required training events.

Qualifications

• Bachelor's degree in engineering, Chemistry, Biology, Life Sciences, or related technical
  discipline.
• Minimum 5 years of progressive experience in Quality Systems, Regulatory, or related functions in a regulated industry.
• Demonstrated experience with CAPA, deviations/nonconformances, investigations, change control, risk management, and audits.
• Experience working cross-functionally with Manufacturing, Engineering, QC, Validation, Regulatory, and Quality Assurance.
• Experience interpreting regulations (ISO 13485, ISO 14971, FDA 21 CFR Part 211, FDA 21 CFR Part 11, FDA 21 CFR Part 820), standards, procedures, and Quality Agreements.