Senior Manager, Quality Systems

Job title: Senior Manager, Quality Systems

About the Role The Senior Manager, Quality Systems will join our Lingo team on-site in Alameda, CA. You will ensure the effectiveness of the quality system and consistent compliance with LRGS, implementing and managing a structure that enables a reliable deployment of quality systems, and coordinating across functions to raise awareness and compliance.

What You'll Do

• 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.

What We're Looking For

• 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.
• Certification is a plus (such as ASQ).
• Effective verbal and written communication with diverse audience and team.
• Analytical thinking with good problem-solving skills.
• Experience managing and leading a team.
• 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.

Compensation & Benefits

• The base pay for this position is $130,700.00 – $261,300.00 per year. In specific locations, the pay range may vary from the range posted.
• Benefits include access to the Health Investment Plan PPO medical plan in the next calendar year, a retirement savings plan with high employer contributions, tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit.
• Abbott is an Equal Opportunity Employer and is committed to employee diversity.