Sr. Quality Engineer

Abbott • Lake Forest, IL

1d

About The Position

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. This position, Sr. Quality Engineer, works out of our Lake Forest, IL and Willis Tower, IL location in the CMI Division. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. As a Quality leader, your main responsibility will include ensuring the quality standards and procedures are upheld in all site and operational processes. Role expectations will include leading a team in monitoring, evaluating, and improving operational efficiency and effectiveness while maintaining compliance with regulatory requirements and company standards.

Requirements

• 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%

Nice To Haves

• 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.

Responsibilities

• Quality Assurance Oversight: Oversee the implementation and maintenance of quality assurance processes and procedures throughout all site and operational activities.
• Team Leadership: 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.
• Process Improvement: 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.
• Quality Management and Monitoring: 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.
• Compliance Management: Ensure compliance with industry regulations, company policies, and quality standards, and implement corrective actions as needed.
• In addition, 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.
• Possible mentorship and coaching: 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.
• Decision Making and Problem Solving: 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.
• Data Analysis and Documentation: 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.
• Cross-Functional Collaboration: 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.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees