Senior Quality Systems Leader – Compliance & Strategy

RXinsider LTD.; Alameda (CA); Hybrid; USD 131,000 - 261,000; Full time

Job summary

Abbott is seeking a Senior Manager, Quality Systems to ensure the effectiveness of the quality system and compliance with LRGS. This on-site role in Alameda, CA drives process rigor, coordinates between functions, and implements a scalable quality structure across Abbott Lingo.

The ideal candidate has a strong background in quality systems, regulatory knowledge (FDA/ISO/EN), and experience leading teams in a regulated medical-device environment.

Qualifications

• Bachelor’s Degree or an equivalent combination of education and experience.
• 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.

Responsibilities

• 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.

Skills

Leadership

Verbal & written communication

Analytical thinking

Problem solving

Regulatory awareness

Quality systems

Education

Bachelor’s Degree or equivalent

Job description

Abbott is seeking a Senior Manager, Quality Systems to ensure the effectiveness of the quality system and compliance with LRGS. This on-site role in Alameda, CA drives process rigor, coordinates between functions, and implements a scalable quality structure across Abbott Lingo.

The ideal candidate has a strong background in quality systems, regulatory knowledge (FDA/ISO/EN), and experience leading teams in a regulated medical-device environment.