Abbott
Healthcare
Engineer,Sr.QualityAssurance
“Engineer, Sr. Quality Assurance at Abbott. Skills: Quality Assurance, CAPA process, Regulatory compliance. Analyze Quality System data. Present established metrics”
Industry & Context.
Problem-solving methodologies; Root cause investigations; Gap analysis
Continuous sitting, Continuous standing, Continuous walking
What They're Looking For.
Must Have
Bachelor's Degree in Engineering or Technical Degree, 3+ years experience in CAPA process ownership, Conduct root cause investigations, Develop action plans/effectiveness checks
Nice to Have
Project management and leadership skills, Lead multi-departmental project teams, Resolve quality system issues, Multitasks, prioritizes, meets deadlines, Organizational and follow-up skills, Attention to detail, Verbal and written communications, Communicate at multiple levels, Experience in broader enterprise/cross-division model, Work in highly matrixed environment, Work in geographically diverse business environment, Work within a team, Work as individual contributor, Advanced computer skills, Gap analysis skills, Report writing skills, Detailed knowledge of FDA, Detailed knowledge of GMP, Detailed knowledge of ISO 13485, Six Sigma certification
What You'll Do.
Analyze Quality System data
Present established metrics
Investigate quality system corrective actions
Resolve quality system corrective actions
Investigate preventive actions
Resolve preventive actions
Support internal audits
Support external audits
Work with cross functional teams
Develop quality improvement plans
Ensure compliance to ISO 13485
Ensure compliance to 21CFR 820
Provide support for interpretation of regulations
Lead activities to implement improvements
Apply problem-solving methodologies
Identify quality issues
Prioritize quality issues
Communicate quality issues
Resolve quality issues
Implement process improvements
Enhance product quality
Reduce process variance
Identify improvement opportunities
Analyze quality audit findings
Recommend modifications in products
Recommend modifications in processes
Identify opportunities for system compliance improvement
Support Divisional initiatives
Support Quality Management Systems (QMS)
Support Environmental Management Systems (EMS)
How You'll Work.
Team & Collaboration
Cross functional teams; Multi-departmental project teams
Communication Scope
Verbal communications; Written communications
Process & Methodology
Project management, Leadership skills
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