Abbott Principal Software Design Quality Engineer in Santa Clara, California

Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 73,000 people. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.


Primary Job Function:

Conduct quality-related activities to deliver consistent; high quality documents; services; products and processes.

Core Job Responsibilities:

Responsible for implementing and maintaining the effectiveness of the quality system for the development of product software.

  1. General - Develops local strategy which is aligned with the business strategy and implements related tactical activities. Translates strategic needs of the division into executable long-range programs and projects. Provide solutions to a wide range of difficult problems. Solutions are compliant; innovative; thorough; practical and consistent with organizational objectives. Leads projects with cross-functional broader scope. Represents team on cross-functional projects with other functional leaders. Directly influences project direction and scope. Interacts effectively with employees; manager; and cross-functional peers. Excels in effective and positive communications. Contributes functional skills and expertise broadly. Scope includes one or more QA functions with general knowledge of other related disciplines. Provides guidance and trains other Professionals and Technicians. May provide oversight to one or more QA professionals and/or contractors.

  2. Quality System Compliance - Demonstrates complete understanding of the standards and regulatory bodies that regulate our industry. Ensures compliance to Division and Corporate policies and procedures. Implements and maintains effectiveness of ADD's Quality System; including the Subsystems and Key processes that govern the area by identifying compliance risks.

  3. Risk Management - Defines the business results expected from risk management strategies and projects. Leads ADD in determining the changes; improvements; and investments needed to support the Risk Management process in the Quality System and business driven objectives. Makes independent decisions within broad parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system. Reviews and approves Risk management documentation.

  4. Complaint Evaluation - Investigates complex complaints and carries out tasks with management guidance. Provides overall direction. Ensures compliant documentation in cross-functional areas of support.

  5. Design Control / Documentation & Change Control - Demonstrates a strong working knowledge of the potential global impact of changes including safety and efficacy. Acts as Process Owner and represents the site as an SME or Process Community Member. Negotiates complex changes. Identifies key processes that may be impacted as a result of the change. Effectively reviews and discusses changes with key stakeholders.

  6. Quality Engineering - Draws conclusions reflecting broad business and quality needs. Champions new initiatives and acts as the catalyst for change within and potentially across divisions. Negotiates complex quality decisions. Participates as SME in audits. Acts as a consultant at site and Division or in partnership with supplier for developing quality related strategies for major projects.

  7. Validation - Acts as site SME in audits for all aspects of validation (minimum 2 subsections). Acts as a consultant at site and Division or in partnership with supplier for developing validation strategies for major projects.

Position Accountability / Scope:

· Receives little detailed or general direction.

· Responsible for ensuring compliant documentation in cross-functional areas of support.

· Carries out tasks with management guidance; typically is responsible for decision making.

· Decisions have long term impact; aligned with the organization strategy.

Minimum Education:

Apprenticeship or Bachelor’s degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience.

Minimum Experience / Training Required:

· At least 8 years work experience in Quality or related filed experience; Less experience may be appropriate with advanced degree.

· Has experience in the health care industry.

· Has experience working with software development teams

· Has a history of completing successful cross-functional projects and driving positive compliance outcomes.


Operations Quality


ADD Diagnostics


United States - California - Santa Clara









Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

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

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Abbott is about the power of health. For more than 125 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 150 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. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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