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Validation Quality Engineer jobs in United States
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Abbott · 12 hours ago

Validation Quality Engineer

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Validation Quality Engineer will manage quality validation activities, conduct QA reviews of validation deliverables, and guide teams through the validation lifecycle phases of the Pegasus project.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

The candidate will manage the quality validation activities of the area assigned
The candidate will be responsible of first QA review of validation deliverables like validation change control, DQ documents (SIA, URS, FRS, DS, TM, and FMEA and risk assessment), IQ, OQ, ES, PQ, PV, CV and variations
The candidate as a Validation quality Engineer SME will coach and guide the workstream team through the validation lifecycle phases of the Pegasus project
The candidate will foster a culture of GOOD Engineering Practices (GEP), Food Safety, regulatory and compliance standards
The candidate will act as a liaison between Engineering, Quality Engineers, and Quality Systems, plant/division/Corporate, on all incidents or topics related to Pegasus validation systems of areas assigned
The candidate will be an active member of the Validation Review Board (VRB)
The candidate will be responsible to escalate to the Validation Governance validation topics requiring clarification or further guidance

Qualification

Validation deliverables reviewValidation lifecycle managementEngineering PracticesRegulatory complianceRisk assessmentCoachingGuidingLiaison skillsActive participation

Required

The candidate will manage the quality validation activities of the area assigned
The candidate will be responsible of first QA review of validation deliverables like validation change control, DQ documents (SIA, URS, FRS, DS, TM, and FMEA and risk assessment), IQ, OQ, ES, PQ, PV, CV and variations
The candidate as a Validation quality Engineer SME will coach and guide the workstream team through the validation lifecycle phases of the Pegasus project
The candidate will foster a culture of GOOD Engineering Practices (GEP), Food Safety, regulatory and compliance standards
The candidate will act as a liaison between Engineering, Quality Engineers, and Quality Systems, plant/division/Corporate, on all incidents or topics related to Pegasus validation systems of areas assigned
The candidate will be an active member of the Validation Review Board (VRB)
The candidate will be responsible to escalate to the Validation Governance validation topics requiring clarification or further guidance

Benefits

Medical and Prescription Drug Plans
Dental Plan
Vision Plan
Health Savings Account (for High Deductible Health Plans)
Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
Supplemental Life Insurance
Short Term Disability (coverage varies by state)
Long Term Disability
Critical Illness, Hospital coverage, Accident Insurance
MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
401(k)

Company

Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.

Funding

Current Stage
Public Company
Total Funding
$6.79M
2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO

Leadership Team

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Robert Ford
President & Chief Executive Officer
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Mike Peterson
Senior Vice President
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Company data provided by crunchbase