Veterans at Abbott
Abbott Senior Analyst, Quality Assurance - Abbott Diabetes Care in Alameda, California
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 103,000 colleagues serve people in more than 160 countries.
Interpret applicable internal and external requirements and translate to produce documents such as procedures and
partnership agreements that are in line with the Quality System. Define process improvements to ensure consistent
implementation of internal requirements and external laws, regulations, guidance and standards.
• Identify internal requirements and external laws, regulations, guidance and standards (LRGS) applicable to one or more of
division's quality systems
• Interpret applicable internal requirements and external LRGS and incorporate into requirements for use in business
processes internally or with external partners.
• Identify areas of potential noncompliance within Abbott or with external partners.
• Assist in the development, review, approval, and change control of Quality System and/or external partnership related
• Participate cross functionally and across business units to standardize Abbott business quality system policies and
• Ensure internal activities and external partnership activities meet applicable regulations and quality standards including
FDA QSR and ISO 9001/ ISO 13485
• Ensure external partnership activities meet applicable regulations and quality standards including FDA QSR and ISO 9001/
• Assist in the evaluation, development, and maintenance of Quality Agreements.
• Initiate and maintain design and on-market change notifications between the division and External Partners.
• Lead and implement process improvement initiatives.
• Collect and analyze quality data as needed for monthly metrics and data driven recommendations based on trends.
• Provide support in external inspections/audits.
• Perform other duties as assigned by Management.
Bachelor's degree plus 5+ years of related work experience with a good understanding of specified functional area, or an equivalent combination of education and work experience. 3 years of experience working in Medical Device or Pharmaceutical manufacturing industry. Working knowledge and application of business concepts, procedures and practices and LRGS. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a general knowledge of technical alternatives and an understanding of their impact on the systems environment. Preference will be given to candidate with digital/mobile app technical experience.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com