Senior Manager Quality

Abbott•Des Plaines, IL

11d

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. The Opportunity At Molecular Diagnostics, we realize the potential of personalized care as the laboratory’s most trusted and preferred source for molecular diagnostic solutions. We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics. The position of Senior Manager Quality within our Molecular Diagnostics Business Unit located in Des Plaines, Illinois. This position provides leadership and guidance for the quality department with overall responsibility to maintain high quality levels on all products while achieving high efficiency. Responsible for Nonconformance/CAPA process management and oversight, including Material Review Board, CAPA Review Board, process metrics, quality record approvals, and partnering with cross-functional areas on strategic initiatives. Responsible to lead Global QA initiatives to implement quality systems/processes across the organization and Division achieving quality improvements, cross plant consistency, and regulatory compliance. Responsible for developing goals, objectives, procedures, policies and systems that are in line with company goals and objectives, mission and vision and FDA/ISO regulations. Daily responsibilities include ensuring that the manufacturing quality system requirements are effectively established and maintained, reports on the performance of the quality system to management with executive responsibility for review. Assures the overall quality of products and services meet internal and external customer requirements.

Requirements

Bachelor’s degree in a scientific or technical discipline or related field or a n equivalent combination of education and work experience.
9 years related work experience.
Proven performance in nonconformance management and reduction, value improvement, risk reduction, and cost containment.
Strong project management and people leadership skills.
Ability to work in a highly matrixed and geographically diverse business environment.
Strong leadership skills, including goal setting and providing positive and constructive feedback to build relationships and improve business results.
Effective team collaboration in a fast-paced, changing environment.
Excellent verbal and written communication skills, with the ability to communicate effectively at multiple levels within the organization.

Nice To Haves

Master's Degree in related field

Responsibilities

Oversee and execute the Nonconformance and CAPA subsystems, including Material Review Board (MRB) and CAPA Review Board activities, Material control processes, Investigations and root cause analysis, development and implementation of resolution plans and effectiveness checks to verify corrective actions.
Apply Statistical Process Control (SPC) and process monitoring techniques to ensure product and process stability.
Utilize statistical analysis to interpret data, identify trends, and drive continuous improvement initiatives.
Implement and maintain risk management strategies to mitigate potential issues and ensure compliance with regulatory standards.
Demonstrate strong critical thinking and problem-solving skills to support decision-making and process improvements.
Interacts frequently with internal and external management and senior-level representatives concerning projects, operational decisions, scheduling requirements and or contractual clarifications.
Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. May supervise non-exempt employees.
Keeps the organization's vision and values at the forefront of decision making and action.
Demonstrates effective change leadership.
Builds strategic partnerships to further departmental and organizational objectives.
Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
Makes decisions regarding work processes or operational plans and schedules to achieve department objectives.

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.

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