Quality Assurance Manager

2 days ago

Des Plaines, Illinois, United States Abbott Full time
About the Role

We are seeking a highly skilled Quality Assurance Manager to join our team at Abbott. As a key member of our Quality Assurance Group, you will be responsible for managing the Supplier Quality Assurance Team and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Manage the development and administration of departmental activities of Supplier Assurance while maintaining compliance to, and driving continuous improvement of, related quality assurance programs, policies, process, procedures, and controls.
  • Ensure compliance with Applicable Regulations ISO13485 and CFR820.
  • Define and communicate overall vision and cascaded objectives for the departments.
  • Staff, train, develop, and manage employees.
  • Assess and manage all resource needs within the department.
  • Manage all activities related to Supplier Quality in accordance with policy, including supplier selection and evaluation, material qualification, inspection procedure development, supplier corrective action, supplier assessments, supplier performance reviews, and supplier development.
Requirements
  • Strong knowledge of CFR 820, ISO 9001, and ISO 13485 regulations and standards.
  • Managerial experience is a must.
  • Bachelor's Degree or related field or an equivalent combination of education and work experience.
  • Minimum 5 years related to supplied product quality within an FDA/ISO certified environment.
  • Multi-tasks, prioritizes, and meets deadlines in a timely manner.
  • Strong organizational, planning, and follow-up skills and ability to hold others accountable.
  • Travel up to 30-50%.
  • Minimum experience 7+ years managerial experience in an FDA-regulated environment, including IVD and/or Medical Devices.
  • Experience interfacing with FDA and ISO auditors is a must.
  • ISO 13485 Certified Lead Auditor experience is required.
Preferred Qualifications
  • Strong leadership skills to motivate and enable department employees in meeting objectives.
  • Strong written and verbal communication skills.
  • Experience in departmental budgeting and supervision/training/managing staff.
  • At least 5 years of experience in Purchasing Controls/Supplier Quality.
  • Experience with computers and software application knowledge consistent with engineering environments.
  • Experience working in a broader enterprise/cross-division business unit model is preferred.
  • Ability to work in a highly matrixed and geographically diverse business environment.
About Abbott

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.

We are committed to employee diversity and provide a comprehensive benefits package, including career development opportunities, a competitive salary, and a comprehensive benefits package.

Join us at Abbott and be part of a team that is dedicated to making a difference in people's lives.

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