Quality Systems Compliance Associate

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 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Main Responsibilities

• Maintain effectiveness of the R&D quality system
• Ensure R&D quality system compliance, including internal auditing, validation change control, SOP preparation, documentation management
• Qualification of third party testing laboratories (analytical and microbiological testing laboratories)
• Understand and apply quality system requirements (e.g., Abbott and ISO/IEC 17025)
• Provide practical guidance on management of quality system requirements for R&D functional areas
• Write independently, evaluate the writing of others
• Apply basic computer skills. (Includes word processing, spreadsheets, instrumentation related & Abbott network systems)

Accountability/Scope

Project goals are broadly defined; define project milestones; responsible for timely project completion.

Work independently to meet project timelines and goals

Summarize procedures, data & information to formulate conclusions.

Work collaboratively across groups to meet compliance performance objectives. Actively assume roles of responsibility, such as training or document control.

Qualifications:

B.S degree  in a life or physical science preferred with 7-10 years of experience in laboratory, quality auditor or quality systems role. Experience with summarizing and presenting results both internally & externally; present complex technical data to large and diverse groups. Ability to communicate and train others on quality system and compliance processes and requirements.

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