Director, Instrument Quality Assurance

Responsibilities

• Lead all aspects of the business unit Quality System worldwide, overseeing the entire product life cycle for diagnostic platforms.
• Develop and implement multi-year business and quality strategies as a member of the leadership team.
• Ensure all systems operate in accordance with corporate and worldwide regulatory requirements.
• Provide quality oversight across multiple diagnostic platforms, including Immunoassay, Clinical Chemistry, and Hematology.
• Manage global Quality System elements including Compliance, Design QA, CAPA, Operations QA, and Incoming QA.
• Serve as the Management Representative for the Quality System and interface with the FDA and other regulatory agencies.
• Coach, develop, and motivate the organization to build a sustainable pipeline of leaders.

Requirements

• Bachelor’s degree in a related field or an equivalent combination of education and work experience.
• 8+ years of experience leading an organization in quality or a medical device/pharmaceutical related discipline.
• Deep knowledge of Quality System Regulations and international regulatory requirements for medical device manufacturing and distribution.
• Advanced leadership skills with the ability to build and develop large organizations.
• Excellent verbal and written communication skills.

Benefits

• Career development opportunities within an international company.
• Health Investment Plan (HIP) PPO medical coverage.
• Retirement savings plan with high employer contribution.
• Tuition reimbursement and student debt assistance programs.
• Access to FreeU education benefits for obtaining a bachelor's degree.

About the Company

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 serve people in more than 160 countries with a mission to advance innovative technologies that transform the way the world manages health.