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Director of Quality Assurance Leadership

2 months ago

Pleasanton, California, United States Abbott Laboratories Full time

About Abbott Laboratories

Abbott Laboratories is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

Our Company Culture

At Abbott Laboratories, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:

  • Career development with an international company where you can grow the career you dream of.
  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO.
  • An excellent retirement savings plan with high employer contribution.
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The Director of Quality Assurance leads a management team and technical staff of multiple groups/functions within a business unit/product specific division Quality organization responsible for ensuring product safety, reliability, and quality. In this role, the Director will ensure that processes and staffing are appropriately developed and implemented to maintain the quality system, set strategic vision/goals in alignment with site organization and division, ensure compliance within organization to all applicable internal requirements and external regulations, establishes quality systems and plans to assure manufacture of the highest quality products to exceed customer requirements. May interfaces with outside regulatory agencies as an Abbott representative. Areas of responsibility may include but not limited to site specific quality assurance/engineering, support functions and/or divisional functions.

Key Responsibilities

  • Recruits, coaches and develops organizational talent.
  • Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
  • Creates an entrepreneurial environment.
  • Provides general direction to managers, exempt specialists and non-exempt support in various areas, groups and/or operations.
  • Keeps the organization's vision and values at the forefront of decision making and action.
  • Demonstrates effective change leadership.
  • Builds strategic partnerships to further departmental and organizational objectives.
  • Interacts internally and externally with executive level management, outside regulatory agencies, customers, vendors and/or suppliers.
  • Coordinates across functional areas, business units, and/or geographies in order to achieve company or area goals.
  • Utilizes technical/professional knowledge and skills to establish, interpret and execute company policies in a major segment of the company.
  • Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
  • Makes and executes operational decisions with a strategic perspective.
  • Directs and controls the activities and budget of one or more functional areas, divisions, product groups and/or operations.
  • Establish Quality Systems that are in compliance with regulatory requirements and meet business needs.
  • Reviews, analyzes and presents to senior staff and other groups the effectiveness of the Quality System.
  • Recommends and implements changes to the system as the result of changing regulations and/or business needs.
  • Analyzes data, makes decisions or provides recommendations to senior staff regarding quality related crises (e.g. patient injury due to product malfunction).
  • Communicates quality policies, strategies and procedures to the organization through written documents, presentations and discussions.
  • Monitors progress of departments or units toward divisional and company goals; monitors all costs associated with assigned organizational unit; monitors company-wide indicators such as market share and profitability; monitors industry trends and external environment in areas relevant to the assigned organizational unit.
  • Develops and/or identifies new work processes that will have broad applicability throughout the company; contributes ideas for improving work processes and achieving organizational goals; investigates and solves problems that impact work processes and personnel in multiple units or departments; develops and communicates a vision for a major segment of the organization.

Requirements

  • Bachelor's degree and 16+ years related work experience.
  • Strong Quality Leadership function experience (3+ at Director level).
  • Experience working with Class III devices.

Preferred Qualifications

  • Master's degree preferred.

Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott Laboratories for diverse opportunities with a company that can help you build your future and live your best life. Abbott Laboratories is an Equal Opportunity Employer, committed to employee diversity.