Abbott

Healthcare

Engineer,Sr.QualityAssurance

$78–156k Plano, Texas, United States FULL TIME
The Brief

“Engineer, Sr. Quality Assurance at Abbott. Skills: Quality Assurance, CAPA process, Regulatory compliance. Analyze Quality System data. Present established metrics”

Industry & Context.

Healthcare
Problems you'll solve

Problem-solving methodologies; Root cause investigations; Gap analysis

Eligibility Requirements

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

Free ATS check

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