Job Details

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

The Senior Director, Technical Quality establishes, maintains, and improves quality system programs, policies, procedures, compliance, and best practices across the Division. This position provides Abbott Diabetes Care (ADC) Division Quality leadership for Design Control, Design Transfer to Manufacturing, on-market risk assessments, and product portfolio risk management. The role supports new product development, changes to on-market products, risk assessments, and ensures proper transfer of design changes into manufacturing, including complaint investigations. This scope applies to all ADC sites and involves leading functional areas such as Digital (App, Cloud & API), Hardware, Non-Product Software, and Risk Management, working with multiple ADC functions including R&D, Operations, and Regulatory Affairs.

The leader translates the vision for quality assurance into organizational goals, ensuring policies, processes, and procedures meet quality and regulatory standards. They oversee design and development processes, document control, training, and validation systems, and utilize problem-solving skills to address quality needs. The role may require creative and motivating leadership, especially when working with teams and influencing others without direct authority.

What You'll Work On

• Establish, implement, and monitor policies for Product Lifecycle Management, including Design Control, Validation, Storage, Handling, Distribution, and Post Market Data evaluation.
• Maintain communication with senior leadership on critical quality issues.
• Develop quality strategies aligned with business objectives and regulatory compliance.
• Ensure proper documentation for DHF, DMR, and training related to Technical Quality & Design Controls.
• Coordinate with functional groups to monitor and improve product quality processes.
• Oversee design control requirements for externally developed products and services.
• Identify organizational development needs and plan for skill development.
• Authorize cost-efficiency projects to improve division margins.
• Make decisions impacting marketed products domestically and internationally.
• Ensure leadership continuity through talent management and development.
• Interface with regulatory agencies such as FDA and other health authorities.

Qualifications

• Bachelor's Degree in a scientific or technical field required.
• Master's Degree in business or technical field preferred.
• Minimum 15 years of experience in Quality, Compliance, or Technical disciplines within the Medical Device or FDA-regulated industry.
• Proven leadership experience.
• Effective communication skills with all levels of the organization.
• Ability to influence cross-disciplinary decisions to maintain quality and customer satisfaction.

Key Success Factors

• Technical expertise in global medical device standards (e.g., IEC 62304, IEC 60601, ASTM).
• Strong stakeholder engagement and collaboration skills.
• Innovation and adaptability to evolving technology and regulations.
• Deep regulatory and compliance knowledge.
• Robust risk management skills following ISO 14971.

APPLY NOW

Learn more about our health and wellness benefits at www.abbottbenefits.com. Follow your career aspirations with Abbott, a diverse and inclusive employer. 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 ranges from $216,700.00 to $433,300.00. In specific locations, the pay range may vary.