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Abbott · 9 hours ago

Quality Engineer II - Risk Management

United States - California - Pleasanton

Full-time

Onsite

Entry, Mid Level

$82K/yr - $141K/yr

2+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. They are seeking an experienced Quality Engineer II - Risk Management to work closely with cross-functional teams to establish compliance and quality for product-related risk management documentation.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Perform risk evaluations associated with post market data, give guidance to risk evaluations for product development

Perform Health Hazard and Regulatory Risk Evaluations

Works cross functionally with development/manufacturing/quality/regulatory/clinical to establish product risk documentation

Demonstrates compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments

Maintains positive and cooperative communications and collaboration with all levels of employees, customers, and contractors

Proactive in finding quality improvements related to Risk Management processes

Qualification

Risk ManagementQuality Systems AuditingFDA RegulationsCertified Quality EngineerGMP KnowledgeAnalytical SkillsCommunication SkillsProject ManagementLeadership SkillsOrganizational Skills

Required

Bachelor's Degree in an in Engineering or related field

Minimum 2 years or an equivalent combination of education and work experience

Must possess good communication and analytical skills

Ability to work under deadlines

Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner

Demonstrates technical leadership within the department and outside the department

Ability to work in a highly matrixed and geographically diverse business environment

Ability to leverage and/or engage others to accomplish projects

Strong organizational and follow-up skills, as well as attention to detail

Ability to travel, including internationally

Preferred

Preferably in an Implantable Medical device, regulatory environment or pharmaceutical manufacturing. Preferred understanding of complaint management and Health Hazard Assessments for on-market (distributed) product

Credentials of a Certified Quality Engineer are a plus

Knowledge of GMP, ISO, FDA regulations, and quality systems auditing is desired