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Principal Quality Professional, Software Verification and Validation

Company: Abbott Laboratories
Location: Santa Clara
Posted on: June 12, 2021

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 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 processes.

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

Required

  • 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 degree.
  • Has experience in the health care industry.
  • Has a history of completing successful cross-functional projects and driving positive compliance outcomes.

Preferred

  • 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 instruments

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 communities

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 @AbbottGlobal.

Keywords: Abbott Laboratories, Santa Clara , Principal Quality Professional, Software Verification and Validation, Other , Santa Clara, California

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