Director, Quality Assurance - Abbott Vascular

Abbott • Temecula, CA

10d

About The Position

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 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott At Abbott, 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 Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year 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 To ensure Design Control activities are robust in ensuring the highest quality and reliability of products from concept through manufacturing. Ensures that development products have the appropriate characterization and validation data to demonstrate that business objectives have been met, prior to formal transfer to manufacturing. What You’ll Work On 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. Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, BSI regulations, etc.). Recommends and implements changes to the Quality System as the result of changing regulations, continuous improvement and/or business needs. Ensures rigorous and diligent Design Control practices, including data-driven stage-gate reviews, robust characterization and validation, and stakeholder-focused success criteria for all stages, including manufacturing transfer and commercial readiness Ensures that appropriate specifications are assigned for materials, process parameters, in-process and finished good testing, etc, and that these specifications are justified with appropriate characterization and validation data. Demonstrates strong product knowledge, problem solving, change management, results orientation, and data-driven decision making. Builds strategic partnerships with internal stakeholders, including operations, regulatory affairs, R&D, clinical, operations QA, and ensures alignment of goals and critical success factors for product development, approval, and manufacturing needs. Interacts internally and externally with executive level management, outside regulatory agencies, customers, vendors and/or suppliers.

Requirements

• Bachelor's degree required in a related field or a n equivalent combination of education and work experience
• Minimum 12 years of relevant career experience required
• Creates mid- to long-range QA R&D plans to carry out objectives established by top management; develops and calculates a budget for one or more departments to meet organizational goals; forecasts future departmental or group needs including human and material resources and capital expenditures; determines and establishes organizational structure and supervisory relationships subject to top management approval.
• Typically makes decisions that translate programs established by top management into operational plans and schedules; work is performed without appreciable direction; consequences of erroneous decisions or recommendations would normally result in failure to achieve goals critical to the major objectives of the organization and would seriously affect the financial, employment, or public relations position of the company.
• 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.
• 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 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.

Nice To Haves

• Master's degree preferred

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.
• Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, BSI regulations, etc.).
• Recommends and implements changes to the Quality System as the result of changing regulations, continuous improvement and/or business needs.
• Ensures rigorous and diligent Design Control practices, including data-driven stage-gate reviews, robust characterization and validation, and stakeholder-focused success criteria for all stages, including manufacturing transfer and commercial readiness
• Ensures that appropriate specifications are assigned for materials, process parameters, in-process and finished good testing, etc, and that these specifications are justified with appropriate characterization and validation data.
• Demonstrates strong product knowledge, problem solving, change management, results orientation, and data-driven decision making.
• Builds strategic partnerships with internal stakeholders, including operations, regulatory affairs, R&D, clinical, operations QA, and ensures alignment of goals and critical success factors for product development, approval, and manufacturing needs.
• Interacts internally and externally with executive level management, outside regulatory agencies, customers, vendors and/or suppliers.

Benefits

• Career development with an international company where you can grow the career you dream of
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees