Sr Director, Design Quality

Abbott Laboratories; Los Angeles (CA); On-site; USD 219,000 - 437,000; Full time

Benefits offered by this job

Free medical coverage

Strong retirement plan

Tuition reimbursement

Job summary

Abbott is seeking a seasoned leader to head Design Assurance and Design Controls for implantable medical devices. You will ensure compliance with regulatory requirements and quality systems across the product lifecycle, working with R&D and cross-functional teams to deliver safe, reliable devices.

You will oversee the design control processes, drive risk-based decision making, and lead preparations for regulatory inspections.

Qualifications

• Bachelor’s Degree in Life Science, Engineering or related field.
• 10+ years of experience across quality, regulatory, manufacturing, or operations for FDA-regulated products.

Responsibilities

• Lead and oversee the Design Assurance organization across software, electrical, mechanical, systems, and clinical quality functions.
• Establish and maintain compliant design control processes through product lifecycle.
• Partner with R&D, Regulatory Affairs, Clinical, Manufacturing and other teams to ensure integrated quality.
• Drive risk-based decision making to ensure patient safety and regulatory compliance.
• Lead regulatory inspection and audit readiness activities related to design controls and product development.

Skills

Design Assurance

Quality leadership

Risk management

Cross-functional collaboration

Education

Bachelor's Degree

Job description

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.

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.

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 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.

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.

Job Details

• 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.
• Location: United States > Sylmar : 15900 Valley View Court
• Work Shift: Standard
• Travel: Not specified
• Medical Surveillance: No
• Significant Work Activities: Keyboard use (greater or equal to 50% of the workday)

Employment Equity

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

Abbott is an Equal Opportunity Employer, committed to employee diversity.

About Abbott

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more.

With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.