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Abbott · 8 hours ago

Quality Engineer II

Minneapolis, MN

Contract

Onsite

Mid Level

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Quality Engineer is responsible for developing, implementing, and maintaining effective process control systems that support product development, qualification, and ongoing manufacturing while ensuring compliance with internal quality standards and external regulatory requirements.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Identify, develop, and implement effective process control systems to support product development, qualification, and ongoing manufacturing activities

Lead the implementation of process assurances, control strategies, and Corrective and Preventive Action (CAPA) systems to meet or exceed internal and external requirements

Assist in the development and execution of streamlined business systems to effectively identify, investigate, and resolve quality issues

Apply structured and systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues

Design, plan, and conduct experiments (DOE) to support process optimization and continuous improvement initiatives

Develop and maintain accurate documentation including experimental protocols, reports, and technical summaries

Lead process control and monitoring of Critical-to-Quality (CTQ) parameters and specifications

Lead and implement product and process improvement methodologies such as Lean Manufacturing and Six Sigma

Lead investigations, resolution, and prevention of product and process non-conformances

Participate in or lead cross-functional teams, representing the Quality function as a core team member in decision-making processes

Lead the completion, review, and maintenance of risk analysis activities (e.g., FMEA)

Collaborate with Design Engineering to support product verification and validation activities

Work closely with Microbiology to ensure appropriate environmental monitoring and incorporation of microbiological requirements into product and process development

Support company-wide initiatives related to Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory compliance

Ensure compliance with U.S. Food and Drug Administration (FDA) regulations, other applicable regulatory requirements, company policies, procedures, and work instructions

Maintain positive, collaborative communication with employees, customers, contractors, and vendors at all levels

Qualification

Quality EngineeringFDA RegulationsLean ManufacturingSix Sigma CertificationProcess ValidationRisk ManagementStatistical AnalysisDocumentation SkillsCommunication SkillsCross-Functional Leadership