Quality Engineer

About the role

The Quality Engineer supports quality, production, and process requirements for Pall Corporation Timonium. This role reports to the Quality Manager and is part of the Quality Assurance department.

Responsibilities

• Lead and coordinate customer quality complaint investigations, performing structured root-cause analysis (e.g., 8D, Fishbone diagram, FMEA, Pareto Analysis) and driving effective and on-time CAPA resolution.
• Administer and maintain document-controlled databases to assist in Standard Operating Procedures, CAPA traceability, and SPC data collection.
• Apply expertise in ISO 9001:2015 and be familiar with upcoming ISO9001:2026 and internal Quality Management System (QMS) procedures, maintaining and generating quality documentation such as inspection reports, First Article Inspection records (FAI), APQP, PPAP, Submissions.
• Support customer/regulatory audits, write clear technical reports, and coordinate actions across Manufacturing, Engineering, Supply Chain/Logistics, and Supplier Quality, ensuring containment is communicated plant-wide and supply continuity is protected.

Requirements

• Bachelor’s degree in engineering or quality with 5+ years of Quality experience, or 15+ years of equivalent experience in Quality within a manufacturing environment in regulated industries such as medical devices or microelectronics.
• Demonstrated success working under a formal QMS with strong discipline in documentation, change control, training records, and compliance to applicable frameworks such as CAPA expectations, ISO management-system requirements, and customer specific requirements.
• Ability to investigate customer complaints fast, drive containment, lead structured root-cause analysis, implement corrective actions, and verify effectiveness with objective evidence.
• Hands-on experience with process controls (SPC/capability basics), inspection strategy, measurement system readiness (MSA/Gage R&R, Calibration Protocols), and qualification/validation activities to ensure processes consistently meet CTQ requirements.
• Proven ability to support customer/regulatory audits, write clear technical reports, and coordinate actions across Manufacturing, Engineering, Supply Chain/Logistics, and Supplier Quality, ensuring containment is communicated plant-wide and supply continuity is protected.

Qualifications

• Previous experience with SmartSolve, Minitab, Microsoft Power Apps, M365, and Power BI software.
• Knowledge of Kosher and Halal certification requirements.
• Related professional certifications such as ASQ CQE, CQA, and Six Sigma.

Benefits

The annual salary range for this role is $75,000 - $120,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This job is also eligible for bonus/incentive pay. We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Check out our benefits at danaherbenefitsinfo.com.