Senior Quality Assurance Specialist – CAPA

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 107,000 colleagues serve people in more than 160 countries

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 107,000 colleagues serve people in more than 160 countries

About Abbott:

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 Rosa, CA currently has an opportunity for a Senior Quality Assurance Specialist - CAPA. The position is part of a team responsible for maintaining and improving the laboratory quality management system (QMS) to ensure compliance to applicable laboratory quality regulations and Abbott policies. The position may work with lab operations teams to plan quality improvement and test method development activities, perform risk management, manage changes to existing methods and processes, and to support other lab essential programs.

This job description will be reviewed periodically and is subject to change by management.

WHAT YOU’LL DO:

• Works on problems of diverse scope and complexity where analysis of data, and considerable judgment and initiative are required to reach resolution or provide recommendation
• Leading and/or contributing to system, test method, quality assurance, and operational process improvement projects
• May manage or support CAPA, training, document control, supplier management and other quality owned processes
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions
• Supporting equipment, process, test method and facility qualification and validation activities
• Supporting external agency and internal audits including management of necessary corrections/corrective actions
• Develop, track and trend Quality metrics as required
• Perform Document Control activities as required
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
• Carries out duties in compliance with established business policies
• Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per CLIA, CAP, ISO and other regulatory agencies, as applicable
• Perform other duties and projects as assigned

EDUCATION AND EXPERIENCE YOU’LL BRING:

Required:

• BS/BA degree or equivalent in chemistry, biology, or other scientific discipline or equivalent experience
• Minimum of five to eight years’ of Quality Assurance experience in a FDA regulated medical device manufacturing environment or ISO certified laboratory, with 3-5 years progressively responsible positions
• Experience implementing, leading, or coordinating electronic Document Control or CAPA program, including practical application of root cause analysis tools
• Thorough knowledge and experience implementing Quality System Regulations ISO 17025, 13485, CLIA, or 21 CFR 820

Preferred:

• Previous experience in a QA role in the IVD industry and/or DOA (Drugs of Abuse) industry is highly desirable, including knowledge of 21 CFR 820, CLIA, CAP and ISO regulations
• Experience with process, equipment, test method validations
• Capable technical writer, able to translate process into concise standard operating procedures
• Experience with MS Office, electronic document control, other electronic quality system tools
• Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor
• Must be detail-orientated, self-motivated and available for flexible scheduling
• Strong communication, problem solving and motivational skills

WHAT WE OFFER:

At Abbott, you can have a good job that can grow into a great career. We offer:

• A fast-paced work environment where your safety is our priority (Manufacturing roles only)
• Production areas that are clean, well-lit and temperature-controlled (Manufacturing roles only)
• 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: http://www.abbottbenefits.com/pages/candidate.aspx

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.