QA Analyst

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.At Abbott Diabetes Care, we believe people with diabetes should have the freedom to enjoy active lives. That''s why we''re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We''re revolutionizing the way people monitor their glucose levels with our new sensing technology.Our Sustaining QA Department at Division HQs in Alameda, CA currently has an opportunity for a ''product-focused'' Quality Assurance Analyst II.WHAT YOU''LL DOIn this role, you''ll be performing verification activities to ensure components and products conform to specified requirements and align with our Quality System protocols. In addition, the position performs test-method validations and provides support to the site calibrations program. You''ll also have opportunities to build cross-functional relationships as part of new product design and on-market development teams. The success with which these responsibilities are exercised is directly related to the integrity of our Operations, Quality, and R&D activities.Core Job Responsibilities:• Perform and approve dimensional, electrical, and cosmetic inspection of raw materials/components.• Perform inspection of components or product for clinical or design verification activities.• Lead in the implementation of new tests, procedures and other activities for new product introduction.• Lead equipment qualifications, software validation, and engineering studies.• Support and analyze ADC''s Site Calibration programs, serving as an alternate Site Calibration Coordinator as required.• Ensures calibration documentation is complete and accurate; Maintains and may provide training on the Calibration Management database; Reviews Calibration certificates against preapproved equipment requirements; Initiates Calibration Event forms & forwards to SMEs to conduct impact assessment; Tracks progress of calibration documentation; Generates metrics from the Calibration Management Database.• Proof artwork and approve final packaging materials/components.• Assist in the development and revision of standard operating procedures and work instructions.• Monitor and report data to senior management.• Participate in continuous improvement initiatives.EDUCATION AND EXPERIENCE YOU''LL BRINGRequired / Minimum Qualifications:• High School Diploma.• 4 years related experience in medical device or pharmaceutical industry. • Demonstrated interpersonal, communication, and organizational skills. • Demonstrated experience working with cross functional groups/teams. • Demonstrated ability to manage activities in order to meet pre-determined deadlines. • Proven ability to work independently while keeping management well informed of activities.• Proficient in the use of various PC / software applications (such as Word, Excel, Project, Access), statistical tools (such as JMP)Preferred Qualifications:• Associate Degree in science or technology preferred.• Knowledge in the areas of Design Controls, VV activities, manufacturing practices or processes, and statistical techniques• Working knowledge applicable regulations and standards such as FDA, QSR and ISO regulations• Excellent attention to detail and accuracy.• Analysis/Critical thinking/Problem-solving skills.• Able to deliver quality outputs under minimal supervision.• Strong technical writing skills to capture complex technical requirements, cause/effect, and risks in design plans, qualifications, FMEAs and investigations.• Strong communications to work with engineers, quality and global operations team members to ensure compliance to division policies.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 contribution is essential to success• 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 communitiesLearn more about our benefits that add real value to your life to help you live fully: 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 on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

Created: 2021-11-29