Quality Systems Engineer, II

4 weeks ago


Cambridge, United States EPM Scientific Full time

Key Responsibilities: Documentation:

Draft and revise procedures to meet regulations, cGMPs, and internal policies. Quality Standards:

Apply and maintain quality standards and procedures for quality systems. cGMP Documentation:

Review cGMP documents and lead or participate in their implementation and storage. Monitoring:

Monitor assigned quality systems and report on their performance. Time Management:

Operate effectively within strict timelines. Additional Responsibilities: Change Control/Design Control:

Oversee and support the process of change control, ensuring clarity, justification, and compliance. Risk Management:

Assist with scheduling, documentation, and data management for the risk management program. Risk Assessment:

Participate in risk assessment, including training, categorization, and reporting. Qualifications: Education:

Bachelor's degree or equivalent with 2+ years of relevant experience. Experience:

Independent decision-making in a cGMP environment, writing/reviewing cGMP documents. Preferred:

Understanding of Medical Device/Biologics FDA regulations. Knowledge of Trackwise or other quality management systems. Risk Management/FMEA experience. Project management and statistical skills. Regulatory inspection SME experience. Group presentation and cross-functional influence experience. Strong communication skills.

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