Quality Engineer

CSL•Boca Raton, FL

About The Position

This position is responsible for providing quality engineering subject‑matter expertise, operational oversight, and continuous improvement for Post‑Donation Information (PDI), Lookback, and Biologic Product Deviation Reporting (BPDR) processes supporting source plasma operations. These processes are deeply integrated with validated computerized systems, including LOGIC, NexLynk, and associated data interfaces. The Quality Engineer serves as the departmental system and process SME, supporting requirements definition, test case development, test execution, and review and approval of computerized system validation deliverables. This role does not own or plan validation activities but provides independent quality review and approval of validation documentation to ensure PDI, Lookback, and BPDR requirements are adequately addressed. To maintain regulatory and procedural proficiency, this role routinely performs standard PDI, Lookback, BPDR, and Quality Control (QC) activities, enabling effective oversight of staff execution and real‑world system performance. Formal system ownership, validation planning, governance, and final approval authority reside with the Manager, Plasma Quality Systems / Quality Assurance.

Requirements

Bachelor’s degree in Engineering, Life Sciences, Quality, Computer Science, or related technical discipline (Equivalent experience may be considered).
5–7 years’ experience in a regulated quality, engineering, or quality systems role.
Experience reviewing and approving computerized system validation deliverables as a business or quality SME.
Hands‑on experience executing regulated quality processes (PDI, Lookback, BPDR, deviations preferred).
Strong analytical and system-thinking capability.
Ability to evaluate validation adequacy relative to regulatory and business requirements.
Experience with UAT execution and test case review.
Excellent written and verbal communication skills.
Ability to influence without direct authority.

Responsibilities

Serve as the Quality Engineering and departmental SME for PDI, Lookback, and BPDR processes and supporting computerized systems.
Identify system and workflow gaps through operational execution, QC review, and trend analysis; provide improvement recommendations to the System Owner.
Translate regulatory and operational needs into defined requirements and risk considerations for system enhancements.
Participate in the definition and review of test cases and acceptance criteria for computerized systems supporting PDI, Lookback, and BPDR processes.
Review and approve validation deliverables (e.g., requirements traceability, test scripts, summaries as the departmental Quality SME, confirming adequate coverage of regulated processes.
Perform and document User Acceptance Testing (UAT) and other user‑level testing activities as required.
Assess validation outcomes and provide documented assurance to the System Owner regarding system fitness for intended use from a PDI/Lookback/BPDR perspective.
Routinely perform standard PDI, Lookback, and BPDR procedures to maintain hands‑on proficiency and support staff during complex or high‑risk cases.
Perform Quality Control review of PDI, Lookback, and BPDR records to verify: Donor and unit suitability determinations, Accuracy and completeness of regulatory submissions, Procedural compliance and data integrity.
Use active case execution and QC review to identify system usability issues, control weaknesses, and training gaps.
Provide expert guidance to Quality Associates, Centers, and stakeholders on PDI, Lookback, and BPDR applicability and regulatory expectations.
Review BPDRs associated with system or process deviations and support responses to FDA‑CBER Additional Information requests.
Support inspections and audits by explaining system controls, validation coverage, and operational use of computerized systems.
Develop and maintain dashboards, metrics, and reports to support oversight of PDI and Lookback activities, timeliness, and trends.
Perform data trending and analytics to identify recurring issues and systemic risks requiring remediation.
Author, review, and revise SOPs and controlled documents related to PDI, Lookback, BPDR, and supporting systems.
Initiate and support deviations, CAPAs, and change controls associated with PDI and Lookback systems.
Maintain confidentiality of donor, product, and company information.
Perform other duties as assigned to support quality and business objectives.