Senior Manager Design Quality

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:

Senior Manager Design Quality

Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity
This position works out of our San Diego, CA location in the Rapid and Molecular Diagnostics, Infections Diseases business. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

As the Senior Manager Design Quality, you’ll be responsible for managing the Design Quality group supporting development of diagnostic products such as instrument, software, reagents and commodities at respective ADD sites. Responsible for implementation of quality policies, processes and procedures of the Design Control subsystem from the Division Quality System and maintaining the effectiveness of the Design Control system at the respective ADD site. Provides oversight and management for the functional areas of the Quality organization. Ensures that the manufacturing quality system requirements are effectively established and maintained, reports on the performance of the quality system to management with executive responsibility for review. Assures the overall quality of products and services meet internal and external customer requirements.

What You’ll Work On

• Establish and execute quality engineering strategies and objectives to support product and non-product development programs

• Works closely with research organization during the entire stage gate process to ensure potential product issues are identified and addressed in the design.

• Provide Subject Matter Expertise in design control including software development life cycle per ISO 62304 and FDA Guidance documents

• Provide Subject Matter Expertise in quality engineering, DOEs, process validation, statistical methods,

• software V&V, design verifications and validations, design controls, and risk management / FMEA

• Support supplier quality with reviewing audit issues and reports

• Communicates effectively on project status, success and risks that could impact customer satisfaction or project objectives.

• Manage the CAPA process, ensuring robust root cause analysis and corrective actions process

• Strategic, multi-disciplined thinker who develops proposals to address issues and resolve project risks.

• Maintains development related documentation and establishes procedures that affect department and R&D sections.

• Independent reviewer of failures and changes during the development phase.

• Plans and initiates projects to improve process flows and identifies adequate control points.

• Develops and controls Design Quality budgets and capital plans.

• Teach and lead the organization in compliance with quality system regulations and standards – particularly those related to Engineering Management

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