Quality Engineer II

Role Summary

Quality Engineer II responsible for providing support for manufacturing processes, review and approval of Process Change Controls, CAPAs and Deviations, and involvement in internal and external audits. Supports new product development and maintains design history files and related records to ensure on-time closure of audit observations.

Responsibilities

• Review and approve CAPAs and Change Controls. Manage Internal and External Audit programs and maintain tracking logs. Capable of managing these programs within the Electronic Quality Management System.
• Evaluate and improve programs to ensure regulatory compliance.
• Perform internal audits as assigned and track implementation of audit observations for on-time closure.
• Lead investigations, perform root cause analysis, prepare investigation reports, and implement corrective actions as needed.
• Perform QA review of new and revised procedures, technical protocols, validations, and reports as assigned.
• Participate in development of customer requirements and design inputs; ensure customer requirements can be validated and design requirements verified.
• Facilitate the Risk Management Process per ISO 14971 and integrate risk management outputs with design, process, and regulatory requirements.
• Design and maintain procedures and systems for process and quality data collection.
• Conduct or support process capability evaluations and determine critical process control points and control limits.
• Support equipment and process validation methods to ensure proper validation prior to implementation and periodic re-validation of critical equipment.
• Conduct gap analyses of in-house practices versus regulations and industry standards; develop corrective actions to ensure continued compliance.
• Act as SME trainer of other QA personnel.
• Performs other related duties as assigned.

Qualifications

• Bachelor’s Degree in engineering or equivalent experience
• Prior experience with review and approval of process change controls, CAPAs, internal/external audits
• Strong knowledge of statistical process control methods and techniques
• Working knowledge and application of ISO 14971 Risk Management for Medical Devices
• Knowledge of GMP/ISO requirements, specifically ISO 13485 Medical Devices
• Knowledge of FDA 21CFR, EU, TGA (Australia), ANVISA (Brazil)
• Working knowledge of cGMPs, QSRs, MDDs, MDR
• Familiarity with Design Control principles
• Working knowledge of Electronic Quality Management System
• Working knowledge of Six Sigma is a plus
• Strong writing and presentation skills

Skills

• Quality management and regulatory compliance
• Root cause analysis and corrective actions
• Audit management and planning
• Process validation and qualification
• Risk management (ISO 14971)
• Data collection and analysis