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Abbott · 1 month ago

Quality Engineer II, Risk Management

United States - California - San Diego

Full-time

Onsite

Entry, Mid Level

$86K/yr - $156K/yr

2+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. As a Quality Engineer II in Risk Management, you will work closely with cross-functional teams to ensure compliance and quality for product-related risk management documentation, while performing risk evaluations and collaborating with various departments.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Perform risk evaluations associated with complaints, manufacturing non-conformances and new product design activities

Proactive in finding quality improvements related to Risk Management processes

Works cross functionally with Engineering, Marketing, Manufacturing and Regulatory to establish product risk documentation

Work collaboratively with operations engineering, complaint handling team, product development and design assurance

Complies 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

GMP knowledgeISO knowledgeFDA regulationsQuality systems auditingProject managementAnalytical skillsCommunication skillsLeadership skillsOrganizational skillsAttention to detail

Required

Bachelors' degree in Engineering or related field or an equivalent combination of education and work experience

2 years' experience working in a broader enterprise/cross-division business environment

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

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