Senior Quality Systems Engineer

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.
• Coordinate data collection and prepare the Quality Management Review for the site and present results to the Director of Quality Assurance.
• Coordinate data collection and prepare the Annual Product Reviews for each customer and for Aphena PL products, and present to the Director of Quality Assurance.
• 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.
• Conduct cross-functional assessments of quality, regulatory, validation, customer, and supply impacts.
• 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 for review/approval by the Director of Quality Assurance.
• 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.
• Any and all other duties as assigned.

Qualifications - Required

• 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 9001, ISO 13485, ISO 14971, FDA 21 CFR Part 211, FDA 21 CFR Part 11, FDA 21 CFR Part 820, FDA 21 CFR Part 110/111), standards, procedures, and Quality Agreements.