Director, Quality Assurance Abbott Vascular

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 114000 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. Youll 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 bachelors 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 Youll 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.

Qualifications

Bachelors degree required in a related field or a n equivalent combination of education and work experience

Masters degree preferred

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.

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

Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal

The base pay for this position is

$168000.00 $336000.00

In specific locations the pay range may vary from the range posted.

JOB FAMILY : Operations Quality

DIVISION : AVD Vascular

LOCATION : United States >

Temecula : Building E - TE

ADDITIONAL LOCATIONS :

WORK SHIFT :

Standard

TRAVEL : Yes 25 % of the Time

MEDICAL SURVEILLANCE :

No

SIGNIFICANT WORK ACTIVITIES :

Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities / Women / Individuals with Disabilities / Protected Veterans.

EEO is the Law link - English :

EEO is the Law link - Espanol : Experience :

Director

Key Skills

Quality Assurance,FDA Regulations,ISO 9001,Root cause Analysis,Biotechnology,Clinical Trials,Quality Systems,Food Processing,Quality Control,Quality Management,cGMP,HACCP

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 168000 - 336000