Quality Systems Engineer, II
4 weeks ago
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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