Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world - in nutrition, diagnostics, medical devices and branded generic pharmaceuticals - that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

At Abbott Molecular, 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.

Our Des Plaines, IL site has an opportunity for a Senior Quality Assurance Professional – Adverse Events within its Quality Team. Conduct quality-related activities to deliver consistent; high quality documents; services; products and processes.

WHAT YOU’LL DO:

General :

• Defines project goals and milestones. Responsible for timely project completion. Provides solutions to a wide range of difficult problems. Ensures that solutions are compliant, innovative, thorough, practical and consistent with organizational objectives.
• May lead projects with cross-functional or broader scope. Interacts effectively with employees, manager, and cross-functional peers.

May represent own team while on cross-functional project teams with other functional leaders. Communicates confidently and effectively with management, peers, and key stakeholders. Implements tactical solutions related to assignment.

Able to contribute functional skills and expertise broadly.

Directly influences project direction and scope.

Scope includes one or more QA functions, with general knowledge of other related disciplines. Provides guidance and trains other Professionals and Technicians.

May provide oversight to one or more QA professionals and/or contractors.

Quality System Compliance:

• Demonstrates good, general understanding of the standards and regulatory bodies that regulate our industry.
• Ensures compliance to site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate.

Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues.

Risk Management:

• Ensures evaluation of product safety and efficacy and elevation of risk-based issues. Creates and reviews risk management documentation to reduce or eliminate risk.
• Makes independent decisions within defined parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system. Authors risk control packages and demonstrates the ability to analyze, evaluate, and control risk decisions by utilizing common practices throughout the quality. Complaint Evaluation - Investigates complex complaints with little management oversight.
• Provides solutions to a wide range of problems. Solutions are compliant, innovative, thorough, practical and consistent with organizational objectives. Ensures compliant documentation in area of responsibility.

Design Control / Documentation & Change Control :

• Formulates thorough reason and justification for change. Identifies critical parameters associated with change.
• Represents the site as an SME or Process Community member.

Quality Engineering:

• Applies solid understanding of quality system elements from product inception through launch. While recognizing project interdependencies and with minimal oversight, leads complex quality discussions across various departments including, as needed, external suppliers.

Validation:

• Acts as Subject Matter Expert (SME) for minimum of at least one respective Validation Subsystem

EDUCATION AND EXPERIENCE, YOU’LL BRING:

• Bachelor’s degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience.
• At least 5 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.

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

Preferred Qualifications:

• Preferred experience in the Healthcare industry.
• Knowledge & experience working in FDA code of Federal Regulations, specifically CFR 21 Part 803 and 806, ISO 13485, MDSAP, EUMDR and IVDR environments.
• Experience related to the evaluation of potentially reportable adverse events and reporting of adverse events to appropriate agencies is required.
• Experience with FDA e- submitter & Web Trader
• Experience related to quality processes including change control, risk management, NCs, complaints, CAPA, internal audit and field safety actions.
• Excellent skills in the areas of leadership, communication, teamwork, problem solving, analytical, organized, strategic thinking, time management, multi-tasking and technical writing.
• Familiarity and/or experience in post market surveillance is a plus.
• Experience or willingness to participate in development of new processes and system upgrades to enhance systems related to adverse events and post market surveillance reporting and trending of serious and non serious incident for IVDR compliance.

WHAT WE OFFER  

At Abbott, you can have a good job that can grow into a great career. We offer: 

• Training and career development, with onboarding programs for new employees and tuition assistance  
• Financial security through competitive compensation, incentives and retirement plans  

• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs 
• Paid time off  
• 401(k) retirement savings with a generous company match 
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities 

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com