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Engineer Sr., Quality jobs in United States
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Abbott · 11 hours ago

Engineer Sr., Quality

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Engineer Sr., Quality role focuses on overseeing quality systems initiatives and ensuring compliance with industry standards.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Must have a proven background in quality / compliance experience to 21 CFR and ISO 13485 and a working knowledge in GMP manufacturing related environments that can be applied to quality situations
Must be a self-starter with solid decision making/critical thinking methodology and able to work independently
Must be able to influence without authority through being able to communicate position and requirements to the TPM
Proficient to act as lead quality representative for representing Abbott QA to internal and external parties
Accountable for leadership and oversight of the quality systems initiatives, including CAPA (Corrective and Preventive Action) systems and Compliance projects
Proposes paths for decision making, can work independently. Ability to assess quality issues with proposed path forward and suggest solutions and implement as needed
Ability to Lead meetings and communications for QA system information. Drives assigned improvement initiatives and corrective actions in quality system initiatives that the individual will lead in collaboration with the TPM

Qualification

Quality compliance experienceGMP manufacturing knowledgeCAPA systems knowledgeSupplier/Internal AuditingOp Excellence/Green BeltDecision makingCritical thinkingLeadershipCommunication skills

Required

Must have a proven background in quality / compliance experience to 21 CFR and ISO 13485 and a working knowledge in GMP manufacturing related environments that can be applied to quality situations
Must be a self-starter with solid decision making/critical thinking methodology and able to work independently
Must be able to influence without authority through being able to communicate position and requirements to the TPM
Proficient to act as lead quality representative for representing Abbott QA to internal and external parties
Accountable for leadership and oversight of the quality systems initiatives, including CAPA (Corrective and Preventive Action) systems and Compliance projects
Proposes paths for decision making, can work independently. Ability to assess quality issues with proposed path forward and suggest solutions and implement as needed
Ability to Lead meetings and communications for QA system information. Drives assigned improvement initiatives and corrective actions in quality system initiatives that the individual will lead in collaboration with the TPM
5-8 minimum years of experience, must be established in GMP and Quality Systems compliance
Project lead skill set or previous manager / Project Manager type experience
Supervisor or manager previous experience preferred to show proven decision making and critical thinking

Preferred

Supplier/Internal Auditing
GMP / GDP working knowledge
Op Excellence/green belt/ black belt

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