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 109,000 colleagues
serve people in more than 160 countries.
ABOUT ABBOTT DIAGNOSTICS:
The key to successful treatment and full recovery is often fast,
accurate diagnosis. Abbott's life-changing tests and diagnostic
tools provide insights that enable smarter, faster decisions and
transform the way the world is managing health.
Our pioneering technology spans the world of healthcare
operations - with medical diagnostic instruments, tests, automation
and informatics solutions for hospitals, reference labs, blood
centers, emergency departments, physician offices and clinics.
Our location in Santa Clara, California currently has an
opportunity for a Principal Quality Professional.
WHAT YOU'LL DO
The Principal Quality Professional within Abbott's Hematology
Division will Conduct quality-related activities to deliver
consistent, high quality documents, services, products and
- 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
- Directly influences project direction and scope.
- Interacts effectively with employees, manager, and
- 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
- May provide oversight to one or more QA professionals and/or
- Quality System Compliance - Demonstrates complete understanding
of the standards and regulatory bodies that regulate our
- Ensures compliance to Division and Corporate policies and
- 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.
- 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
- Reviews and approves Risk management documentation.
- Complaint Evaluation - Investigates complex complaints and
carries out tasks with management guidance.
- Provides overall direction.
- Ensures compliant documentation in cross-functional areas of
- 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
- Effectively reviews and discusses changes with key
- 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
- 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.
EDUCATION AND EXPERIENCE YOU'LL BRING
- 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 filed
experience; Less experience may be appropriate with advanced
- Has experience in the health care industry.
- Has a history of completing successful cross-functional
projects and driving positive compliance outcomes.
- Prior software quality assurance (development / test)
experience and familiarity with IEC 62304: Medical Device Software
- Software life cycle Processes
- Prior experience in design assurance for in-vitro diagnostic
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great
career. We offer:
- Training and career development, with onboarding programs for
new employees and tuition assistance
- Financial security through competitive compensation, incentives
and retirement plans
- Health care and well-being programs including medical, dental,
vision, wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial
performance and history of being actively involved in local
Learn more about our benefits that add real value to your life
to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse
opportunities with a company that provides the growth and strength
to build your future. 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