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Abbott Senior Quality Professional in Lake Forest, Illinois

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 103,000 colleagues serve people in more than 160 countries.

Summary :

This Senior Quality Professional position will support the ADD Quality Management System team in implementation of the new Medical Device Regulations for Invitro Diagnostics (IVDR) into ADD’s Quality System and facilitate reformatting of the quality system procedures and creation of new procedures across the organization.

The ideal candidate has experience in any of the following: updating a quality system to align with a new requirement, authoring new and/or revising quality system processes and procedures or experience with quality system gap assessment process. Project management skills is desirable.

Main Responsibilities:

  • Assists the project team with the goal and milestone achievement for implementation of the new regulation into ADD’s quality system to ensure commercialization of diagnostics products in the European Union.

  • Works collaboratively with a global cross-functional teams to revise existing or establish new quality system requirements/processes and procedures compliant with the new regulation.

  • Ensures solutions are compliance, innovative, thorough, practical and consistent with organizational objectives.

General:

  • Conducts quality-related activities to deliver consistent; high quality documents; products and processes which adds value to the business.

  • Responsible for implementing and maintaining the effectiveness of the quality system.

  • Defines project goals, milestones and responsible for timely project completion.

  • Receives general direction and exercises considerable discretion to work own detail.

  • Recommends possible solutions.

  • Provides solutions to a wide range of difficult problems and decision may have short and long-term impact

  • Interacts effectively with employees; managers; and cross-functional peers.

  • May lead projects with cross-functional or broader scope and 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.

  • Ensures compliant documentation; carrying out tasks relating to area of responsibility with management oversight.

  • 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 noncompliance issues.

Risk Management:

  • 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.

Documentation & Change Control:

  • Identifies critical parameters associated with change.

Education:

Apprenticeship or Bachelor’s degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.

Qualifications/Experience:

At least 5 year’s work experience in Quality or related field experience; less experience may be appropriate with advance degree.

Preferred experience in the Healthcare industry.

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

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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