Senior Manager, Quality Systems - Lingo (on-site) at Abbott

Senior Manager, Quality Systems

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 115,000 colleagues serve people in more than 160 countries.

The Opportunity

Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare.

What You'll Work On

• Recruit, coach and develop organizational talent.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Create an entrepreneurial environment.
• Provide direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments.
• May manage and coach a team of quality assurance employees.
• Keep the organization's vision and values at the forefront of decision making and action.
• Demonstrate effective change leadership.
• Build 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.).
• Make decisions regarding work processes or operational plans and schedules in order to achieve department objectives.
• Develops, monitors and appropriately adjusts the annual budget for department(s).
• Coordinate the implementation of quality system requirements at Abbott Lingo.
• Assess proposed regulations and communicate new requirements to the organization.

Required Qualifications

• Bachelor's Degree or an equivalent combination of education and experience
• Minimum 7 - 9 years related work experience.
• Provides direction and monitors progress of exempt specialists and/or supervisory staff toward departmental goals.
• Monitors costs of projects and of human and material resources within a department or unit.
• Monitors external environment in area of technical or professional responsibility.
• Will perform this job in a quality system environment.
• Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups
• Investigates and solves problems that impact work processes and staff within or across units or departments.
• Communicates the departmental vision for the organizational unit assigned.

Preferred Qualifications

• Advanced degree
• Submission / registration types and requirements
• Effective verbal and written communication with diverse audience and team.
• Analytical thinking with good problem-solving skills.
• Experience managing and leading a team.
• Certification is a plus (such as ASQ).
• Must be able to lead and manage multiple and competing priorities and manage programs.
• Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.
• Experience with medical device software requirements and software regulations.
• Ability to identify risk areas and escalate issues as appropriate.

The base pay for this position is $130,700.00 $261,300.00. In specific locations, the pay range may vary from the range posted.