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, CA currently has an opportunity for Sr. Quality Professional, Software Verification and Validation
WHAT YOU’LL DO
The Sr. Quality Professional, Software Verification and Validation within Abbott’s Hematology Division will conduct quality-related activities to deliver consistent; high quality documents; services; products and processes.
- General - Defines project goals and milestones.
- Responsible for timely project completion.
- Provides solutions to a wide range of difficult problems.
- Ensures that solutions are compliant, innovative, thorough, practical and consistent with organizational objectives.
- May lead projects with cross-functional or broader scope.
- Interacts effectively with employees, manager, and cross-functional peers.
- May represent own team while on cross-functional project teams with other functional leaders.
- Communicates confidently and effectively with management, peers, and key stakeholders.
- Implements tactical solutions related to assignment.
- Able to contribute functional skills and expertise broadly.
- Directly influences project direction and scope.
- 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 good, general understanding of the standards and regulatory bodies that regulate our industry.
- Ensures compliance to site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate.
- Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues.
- Risk Managment - Ensures evaluation of product safety and efficacy and elevation of risk-based issues.
- Creates and reviews risk management documentation to reduce or eliminate risk.
- Makes independent decisions within defined parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system.
- Authors risk control packages and demonstrates the ability to analyze, evaluate, and control risk decisions by utilizing common practices throughout the quality.
- Complaint Evaluation - Investigates complex complaints with little management oversight.
- Provides solutions to a wide range of problems.
- Solutions are compliant, innovative, thorough, practical and consistent with organizational objectives.
- Ensures compliant documentation in area of responsibility.
- Design Control / Documentation & Change Control - Formulates thorough reason and justification for change.
- Identifies critical parameters associated with change.
- Represents the site as an SME or Process Community member.
- Quality Engineering - Applies solid understanding of quality system elements from product inception through launch.
- While recognizing project interdependencies and with minimal oversight, leads complex quality discussions across various departments including, as needed, external suppliers.
- Validation - Acts as Subject Matter Expert (SME) for minimum of at least one respective Validation Subsystem.
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 5 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
- Preferred experience in the Healthcare industry.
- Has a history of completing successful 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 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.