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Abbott Quality Assurance Manager in Menlo Park, California

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 103,000 colleagues serve people in more than 160 countries.

This role is primarily responsible for Supplier Quality and Compliance. Specifically, this role includes organizational oversight and management incoming quality assurance, supplier quality assurance and engineering, as well as internal compliance to regulations (inclusive of internal auditing). This role ensures that systems, processes, and staffing are suitably designed and implemented to maintain an effective/active quality system. The Quality and Reliability Manager will work with their group to: Ensure product safety, reliability and quality through the effective use of quality planning, risk analysis, statistical methods and process controls during the design and manufacturing stages of the product. Ensure efficient compliance to all applicable regulations through the implementation of a robust quality system and through communication/reporting to regulatory authorities. Exceed customer expectations by responding to field events in a professional and timely manner. Minimize the number of field events through effective analysis of returned products, corrective actions and timely investigation and response to field events. Communications with regulatory authorities Reduce costs by employing Quality/Reliability System Processes that result in the development of efficient test and inspection plans, improved yields, and minimized scrap.

Core Responsibilities

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

  • 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 direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. May supervise non-exempt employees.

  • 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.

  • 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.).

  • Makes 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).

  • Provides appropriate level of cross-functional and customer-oriented communications regarding the status of department and quality system operation, as well as product performance.

Influence/Leadership Develops, communicates, and builds consensus for operating goals that are in alignment with the division. Provides leadership to assigned staff and supervisors by communicating and providing guidance towards achieving department objectives.;

Planning/Organization Creates immediate to long-range plans to carry out objectives established by top management; develops and calculates a budget for a department or group to meet organizational goals; forecasts future departmental needs including human and material resources and capital expenditures; recommends or modifies the structure of organizational units or a centralized functional activity subject to senior management approval.

Decision Making/Impact Assignments are expressed in the form of objectives; makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management; consequences of erroneous decisions or recommendations would normally include critical delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity.

Minimum Education: Bachelor's degree and 9+ years of related work experience or an equivalent combination of education and work experience. Advanced degree preferred.

Minimum Experience / Training:

  • Technical/Business Knowledge: 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 company-wide indicators such as market share and profitability; 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.

  • Cognitive Skills: Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups; facilitates others' participation in the continuous improvement program; investigates and solves problems that impact work processes and personnel within or across units or departments; develops and communicates a vision for the organizational unit assigned.

  • Quality System knowledge and Supplier Management experience as preferred.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email