A global job position with an impact:
The Quality Engineer is responsible to ensure that our processes and products are following our Quality System, to improve our Quality system and to improve the quality of our products and processes.
Duties/Responsibilities:
• Develop statistics for relevant areas.
• Present KPI's.
• Perform and responsible for complaint handling.
• Evaluate and make decisions on the system for nonconforming products.
• Ensure that nonconforming products are reviewed and evaluated.
• Ensure that nonconforming products have a disposition.
• Responsible for nonconformities being documented, analyzed, resolved, and justified.
• Promptly create procedures for rework.
• Provide training on reworks.
• Maintain the corrective and preventive system.
• Evaluate KPI's, audits, processes, non-conformities, and other areas to determine if
CAPA's are needed.
• Establish root cause analysis to ensure that the reasons for the CAPA's are being
addressed.
• Identify actions to solve CAPA's.
• Verify that the CAPA's actions are effective.
• Document all CAPA's and actions.
• Responsible for complaint investigation, records, and statistics.
• Lead Quality Inspectors supporting assigned area.
Authority:
• Reject to release the product/lot and escalate any problems to NCR/CAPA
• Reject the release of product/lot, if disagreeing with the disposition of an NCR or CAPA
• Make NCR's, CAPA's and SCAR's following our existing procedures
• Stop manufacturing if production represents a quality risk
• Put product on hold
Education and Experience:
• Bachelor's degree in a related field
• 4+ years of experience working in Quality
• Experience in the medical device industry
• Experience working in manufacturing preferred
• Must be able to read, write, and understand English
Work Environment:
This is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration, or other workplace hazards controlled within compliance of current safety and health standards.
How to Apply:
If you are interested in the position, then please apply as soon as possible through our recruitment system. Note that we will invite candidates for interviews on a continuous basis so no need to hesitate.
This job ad will be online until April 30, 2026, but once we have found the right candidate, this ad will no longer be online. For more information about the position, please feel free to contact at marc@ambu.com.