Abbott
Healthcare
QualityEngineerII
“Quality Engineer II at Abbott. Skills: Quality engineering, Manufacturing support, Continuous improvement, Compliance. Provide quality engineering support for manufacturing operations. Support production activities to ensure compliance”
Industry & Context.
Root cause analysis; Investigation; Analysis
10 % travel, Continuous sitting, Continuous standing
What They're Looking For.
Must Have
Bachelor's degree in Engineering, Science, or related technical field with 3+ years of quality engineering, manufacturing engineering, or related experience, Master's degree in Engineering, Science, or related technical field with 1+ years of quality engineering, manufacturing engineering, or related experience, Experience in a regulated industry
Nice to Have
Medical device industry experience, ASQ Certified Quality Engineer (CQE) or other ASQ certification, Experience with CAPA, complaints, investigations, audits, and risk management, Knowledge of FDA Quality System Regulation and ISO 13485
What You'll Do.
Provide quality engineering support for manufacturing operations
Support production activities to ensure compliance
Assess manufacturing issues
Recommend corrective actions
Lead investigations associated with complaints
Lead investigations associated with nonconforming material
Lead investigations associated with deviations
Lead investigations associated with quality events
Support CAPA activities
Implement corrective actions
Participate in risk assessments
Participate in quality impact evaluations
Identify opportunities to improve product quality
Identify opportunities to improve process performance
Identify opportunities to improve operational efficiency
Utilize quality engineering tools
Support decision-making
Participate in cross-functional improvement initiatives
Support internal audits
Support external audits
Support regulatory inspections
Ensure compliance with FDA
Ensure compliance with ISO 13485
Ensure compliance with MDR
Ensure compliance with company quality system requirements
Maintain complete quality records
Maintain accurate quality records
Maintain complete quality documentation
Maintain accurate quality documentation
How You'll Work.
Team & Collaboration
Manufacturing; Operations; Engineering; Quality teams; R&D; Regulatory Affairs; Supply Chain
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