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Quality Engineering Sustaining Specialist
2 months ago
Job Summary
As a Quality Engineering Sustaining Specialist at ICU Medical, you will play a critical role in overseeing and supporting Metrology operations, ensuring adherence to cGMP requirements. Your main responsibilities will include developing and maintaining measurement programs, assessing measurement systems, and providing technical support for manufacturing operations.
Key Responsibilities:
- Participate in the design, execution, and implementation of protocols related to quality control and manufacturing activities.
- Develop measurement test methods, SOPs, and reports to ensure compliance with regulatory requirements.
- Provide technical training and ensure compliance with measurement protocols and cGMP requirements.
- Assist in interpreting measurement and calibration options to ensure accurate results.
- Conduct Data Integrity/System Audit Trail Review functions for Instrumentation to ensure data accuracy.
- Participate in audits and generate necessary documentation to ensure compliance.
- Provide technical expertise and contribute to project activities to drive business growth.
- Perform other duties as assigned to support the team.
Requirements:
- Understanding of FDA and cGMP regulations to ensure compliance.
- Working knowledge of laboratory instrumentation and medical device systems to ensure accurate results.
- Ability to train others and communicate effectively to ensure knowledge transfer.
- Analytical and critical thinking skills to analyze data and make informed decisions.
- Bachelor's degree in engineering or science field to ensure technical expertise.
- 4+ years of relevant experience in quality control and manufacturing operations.
- Prior experience in medical device manufacturing preferred to ensure industry knowledge.
- Proficiency in Microsoft Excel, Word, PowerPoint, and Outlook to ensure effective communication.
Work Environment:
- Requires lifting up to 50 lbs and standing for moderate amounts of time to ensure physical demands are met.
- Involves computer work, standing, and walking to ensure a safe working environment.
- Travel may be required up to 20% of the time to support business needs.
