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Abbott · 19 hours ago

Sr. Quality Engineer

Lake Forest, IL

Full-time

Onsite

Senior Level

$87K/yr - $173K/yr

5+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Sr. Quality Engineer will ensure quality standards and procedures are upheld in all operational processes, leading a team to monitor and improve efficiency while maintaining compliance with regulatory requirements.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Oversee the implementation and maintenance of quality assurance processes and procedures throughout all site and operational activities

Lead a team of quality assurance specialists, providing guidance, training, and support to ensure their effectiveness in executing quality control measures. Sets standards and monitors staff performance, provide performance feedback, write and conduct performance evaluations for employees, and provide input for recommended merit increases and promotions. Proven experience in leading and motivating teams to achieve quality objectives and drive performance improvements. Adjusts communication style and medium (oral, written, or electronic) to meet the needs of the receiver (direct reports, peers, customers, managers); summarizes data and distills it down to relevant points to enhance understanding and uses appropriate level of language and detail for the receiver. Makes plans to accomplish assigned daily activities and simple projects and establishes priorities so as to handle competing demands. Optimizes use of available resources, estimates time and resources necessary to complete daily tasks or projects

Identify areas for process improvement to enhance efficiency, reduce errors, and optimize resource utilization. Commitment to ongoing learning, development, and implementation of best practices to drive continuous improvement within the team and for the site; champions specific projects. Lead teams to customer oriented solutions that make business sense

Develop and implement systems for monitoring the quality of products, services, and operational processes, including regular audits and inspections. Strong understanding of quality management principles, methodologies, and tools, such as Six Sigma, Lean, and Total Quality Management. Communicate department objectives and results. Exchanges information with employees, peers, and knows when to escalate to management

Ensure compliance with industry regulations, company policies, and quality standards, and implement corrective actions as needed

Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc Identify risk areas within your group and develop strategies to mitigate as necessary. And audit tasks as needed

Assist employees in the creation of development plans and work with employees to meet their development needs. Provide guidance, direction, training, resources, and time. Create an environment of trust and respect within the group while promoting productivity and morale. Listens to different points of view, taking ownership and responsibility for own actions

Bases decisions on the overall good, rather than on benefit to a particular functional area, serves as a champion for specific projects and initiatives. Adapts to and supports change in a timely, positive manner. Utilizes good judgment and makes timely decisions which consider the facts and data at hand; knows when to escalate to management. Strong problem-solving abilities to analyze complex issues, develop innovative solutions, and implement effective corrective actions

Analyze quality data and performance metrics to identify trends, root causes of issues, and opportunities for improvement. Maintain accurate documentation of quality procedures, issues, and resolutions. Prepare regular reports on quality performance for management review. Gather and prepare trend information and recommend areas of focus. Assist in the development and execution of projects to improve processes, reduce costs, and maintain operations

Collaborate with other departments, such as production, engineering, planning, purchasing, and program management, to address quality-related issues and drive continuous improvement initiatives. Manages assigned projects and works cross functionally to identify changes and necessary resources. Identifies and communicates need for change. Contributes to the creation of the team's mission, objectives, and strategies, accepts team decisions and works toward their implementation with others

Travel Requirements: Up to 25% or as needed for the role

Qualification

Quality AssuranceProcess ImprovementCompliance ManagementData AnalysisSix SigmaISO 13485US 21 CFR 820Team LeadershipAudit CertificationsPower BICAPAOperational Excellence

Required

B.S. in Quality or related field experience

At least 5 years of experience in similar role (Less experience may be appropriate with advanced degree)

Ability to travel up to 25%

Preferred

Preferred experience in the Healthcare industry

Has a history of completing successful projects and driving positive compliance outcomes

Audit Certifications preferred such as ASQ Certified Auditor etc

Understanding in the following : US 21 CFR 820 (QSR), ISO 13485, etc. Identify risk areas within your group and develop strategies to mitigate as necessary

Understanding Power BI tools and similar for Data Metrics/analytics

Understanding CAPA, Documentation, and Change Control Processes/Methodology

Operational Excellence experience ideal