Senior Quality Systems Engineer
About The Position
The Senior Quality Systems Engineer is a senior-level Quality professional who supports, maintains, and continuously improves the Quality Management System (QMS) in a highly regulated pharmaceutical, medical device, or combination-product contract manufacturing environment. The role provides technical leadership across quality-system processes, including CAPA, deviations, nonconformances, investigations, change control, risk management, audits, quality metrics, document control, training, supplier quality, and customer quality requirements. It supports a setting with multiple customers, products, manufacturing processes, regulatory requirements, and Quality Agreements, and serves as a senior technical resource and quality leader without direct reports. The position works across Quality Assurance, Manufacturing, Engineering, QC, Regulatory Affairs, Supply Chain, Facilities, Maintenance, and customer Quality organizations. It helps ensure regulatory compliance, inspection readiness, effective investigations and corrective actions, accurate quality records, and a proactive quality culture. The role also prepares site Quality Management Reviews and customer and company Annual Product Reviews for presentation to the Director of Quality Assurance.
Requirements
- Bachelor's degree in engineering, Chemistry, Biology, Life Sciences, or a related technical discipline.
- At least 5 years of progressive experience in Quality Systems, Regulatory, or related functions in a regulated industry.
- Demonstrated experience with CAPA, deviations or nonconformances, investigations, change control, risk management, and audits.
- Experience working cross-functionally with Manufacturing, Engineering, QC, Validation, Regulatory, and Quality Assurance.
- Experience interpreting regulations, standards, procedures, and Quality Agreements, including ISO 9001, ISO 13485, ISO 14971, FDA 21 CFR Parts 211, 11, 820, and 110/111.
Responsibilities
- 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, prepare the site Quality Management Review, and present results to the Director of Quality Assurance.
- Coordinate data collection, prepare Annual Product Reviews for each customer and for Aphena PL products, and present them to the Director of Quality Assurance.
- Provide guidance on QMS requirements and promote a proactive quality culture.
- Lead the CAPA lifecycle from initiation through effectiveness verification and closure.
- Facilitate cross-functional CAPA investigations and evaluate root-cause analyses and action plans using structured methods such as 5-Why, Fishbone/Ishikawa, Fault Tree Analysis, Pareto analysis, and risk-based techniques.
- Lead investigations into manufacturing deviations, process or equipment failures, laboratory events, material discrepancies, documentation errors, environmental excursions, product nonconformances, packaging or labeling issues, and data-integrity concerns.
- Perform product and 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 and 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, and 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.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
