Sr Director, 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 122,000 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 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:

Lead and oversee all Design Assurance and Design Control activities for implantable medical devices, ensuring compliance with applicable regulatory requirements, industry standards, and quality system regulations throughout the product lifecycle. Partner closely with R&D and cross-functional teams to integrate quality into the design process, maintain robust design controls, and deliver safe, effective, and high-quality products that meet user needs, intended use requirements, and customer expectations.

What You’ll Work on:

• Lead and oversee the Design Assurance organization across software, electrical, mechanical, systems, and clinical quality functions.

• Establish and maintain compliant design control processes throughout the product lifecycle, from concept through commercialization and post-market support.

• Partner with R&D, Regulatory Affairs, Clinical, Manufacturing, and other cross-functional teams to ensure quality is integrated into product development.

• Ensure compliance with global medical device regulations, standards, and company quality system requirements.

• Provide quality leadership for design planning, design reviews, risk management, verification, validation, design transfer, and design changes.

• Drive risk-based decision making to ensure patient safety, product reliability, and regulatory compliance.

• Ensure products meet user needs, intended use requirements, and performance expectations through effective quality oversight.

• Serve as the quality authority for product development phase gates, design decisions, and major design changes.

• Lead regulatory inspection and audit readiness activities related to design controls and product development.

• Develop, mentor, and grow a high-performing Design Assurance team while driving continuous improvement of quality processes and organizational capabilities.

Required Qualifications:

•  Bachelor’s Degree, Life Science, Engineering or related disciplines

• Minimum 10 plus years of experience in multiple business disciplines (such as quality, regulatory, manufacturing engineering, operations) with companies engaged in the manufacture of FDA regulated products.

Apply Now

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

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 www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal

     

The base pay for this position is

$218,700.00 – $437,300.00

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

     

JOB FAMILY:

Operations Quality

     

DIVISION:

CRM Cardiac Rhythm Management

        

LOCATION:

United States > Sylmar : 15900 Valley View Court

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

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: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf