12 days old

Software Validation Quality Engineer II

Abbott
Liberty, SC 29657

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

The Software Validation Engineer/Analyst role will work closely with the quality and engineering personnel and various project teams throughout the organization and across multiple sites. In this role, you will help provide regulatory guidance and perform validation duties to ensure all software validation projects and corresponding deliverables adhere to current regulations, industry standards,

Main Responsibilities
• Perform ongoing SW validation activities.
• Assists in the development and execution of validation deliverables.
• Complete validation and validation related paperwork timely and accurately.
• Contribute to the growth and development of the software team related to validation best practices.
• Generate reports and metrics as assigned.
• Support quality/manufacturing engineers for their validation need in manufacturing, labs, facility, utility and other departments.
• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Monitor executions for Validation plan.
• Document work status and report to management frequently.
• Within structure, plan own work, manage several/often concurrent, tasks to accomplish assigned tasks to meet or exceed expectations (cost, quality, time).
• Help provide regulatory guidance to ensure all software validation projects and corresponding deliverables adhere to current regulations.
• Prepare and communicate recommendations and respective action plans.
• Comply with all regulations and standards for quality, Environment, Health, Safety and Energy (EHS&E) Global Policies, Abbott Engineering Standards, and other governance areas as applicable.
• Ensure quality and effectiveness of assigned tasks.
• Identify areas of risk with respect to compliance.
• Offer suggestions to others on how to modify existing process or procedures to improve quality.

Additional Responsibilities may include:
• Assist in development of procedures and standards.
• Assist in audit.
• Project Management skills
• Recognize risks versus the relative gains associated with actions; understand projects. Responsible to meeting established objectives and goals.

Qualifications
• A Bachelor’s Degree in Engineering, Science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence.
• Three to five years’ experience is typical for this position. Previous internships assignment(s) preferred.
• Should be able to quickly gain knowledge, understanding, or skill, and willingly absorb and comprehend Abbott processes, policies, and methods.
• Possesses good human relation skills in both implementing and coordinating efforts involved across several disciplines.
• Interacts well with diverse groups within engineering and maintains strong working relationship with internal and external collaborators.
• Listens to and understands others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentations.
• Works well with other engineers in a collaborative, fast-paced goal-driven environment.
• Possesses interpersonal skills to negotiate and reconcile differences.

","title":"Software Validation Quality Engineer IIDivision: CAHF Cardiac Arrhythmias & Heart Failure
Travel: Yes, 10 % of the Time
Medical Surveillance: Not Applicable
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Categories

Posted: 2019-09-04 Expires: 2019-10-09

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Software Validation Quality Engineer II

Abbott
Liberty, SC 29657

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