Principal Design Quality Professional

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.

Principal Design Quality Professional

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

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.

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• 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

This position works out of our Santa Clara, CA location in the Hematology Division. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are 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 Principal Design Quality Professional, you'll support the Product Development team in Quality and Compliance for developing new launches as required by intended market. Support the transfer of projects to commercial production. Support product improvements and provide guidance on design planning, verification test strategy, and design change impacts. Review and approve Design Inputs, Design Verification protocols/reports, Human Factors studies and Design Validation protocols/reports. Help develop and participate in delivering training to personnel. Review and approve component and subsystem drawings and system architecture.

What You'll Work On

• Work with Software Development and System Engineering in the completion of system/software requirements and other verification and validation processes.

• Work with Reagent/Commodity Development in the completion of requirements and other verification and validation processes.

• Acts as Process Owner and represents the site as an SME or Process Community Member.

• Acts as a consultant at site and Division for developing quality related strategies for major projects.

• Supports quality related strategies for projects, design planning, Design Verification, Design Validation activities, including review and approval of protocols, reports, and problem resolution.

• Develop local strategy aligned with the business strategy and implement related tactical activities.

• Provide solutions to a wide range of difficult problems. Solutions are compliant, innovative, thorough, practical, and consistent with organizational objectives.

• Document and review Trend Analysis, CAPA's and Audit responses.

• Document review and approval of test method validation, process validation, equipment qualifications.

• Provide KPI's and analyze data for metrics reporting.

• Scope includes one or more Quality Engineering functions with general knowledge of other related disciplines.

• Negotiates complex quality decisions. Participates as SME in audits.

• 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.

• Risk Management

• Defines the business results expected from risk management strategies and projects. 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.

• Design Control / Documentation & Change Control

• Demonstrates a strong working knowledge of the potential global impact of changes including safety and efficacy.

• Leads projects with cross-functional broader scope. Represents team on cross-functional projects with other functional leaders.

• Effectively Interacts with employees, manager, and cross-functional peers.

Required Qualifications

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

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

• Has experience in the health care industry.

Preferred Qualifications

• Medical Device or in-vitro diagnostics industry highly desired.

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

• Experience with complex systems (robotics, fluidics, optics).

• Prior software quality assurance (development / test) experience and familiarity with IEC 62304: Medical Device Software

• Software life cycle Processes desirable.

• Cybersecurity experience desirable.

• Experience with diagnostic products preferred.

• Experience with DOORS for requirements management.

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.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 $125,700.00 - $251,500.00. In specific locations, the pay range may vary from the range posted.