Engineering Change Order Analyst

Title: Engineering Change Order Analyst

Location: Milpitas, CA

Duration: 5+ Month

100% Onsite Role

Years Experience:

• Minimum 4 years relevant experience (with bachelor's degree)
• Minimum 7 years relevant experience (without bachelor's degree)

Skills:

• Knowledge of regulations and standards affecting IVDs and Medical Devices
• Related experience with document control and change order systems
• Working knowledge of QSR, ISO standards relating to document and data control
• Education: Bachelors Degree or an equivalent combination of education and work experience.

Duties:

• Assist in developing and maintaining systems within department.
• Maintain software databases supporting quality system data (e.g. PLM (Product Lifecycle Management) database).
• Changes may include product improvement, design corrections and new product development.
• Responsible for implementing and maintaining the effectiveness of the quality system.
• Create, analyze and process Change Items in compliance with QSR, ISO13485 and other applicable standards.
• Assist in expanding the use of Agile software to increase efficiency of Document Control processes.
• Assist in development of configuration management systems.
• Initiate Change Items relating to product structure (bill of materials) and verify quality of submitted Change Items.
• Assist in the development of monthly reports regarding key metrics to track Document Control system effectiveness.
• Participate in project teams to further develop efficient and effective use of Document Services.
• Assist in developing and maintaining a company wide Data Management System.
• Broaden the scope of the Document Services Functions, such as development of Change Control function.
• Create, analyze and process Change Items for new product development and upgrades.
• Support other departments in configuration and modifications of product and sub-assemblies.
• Assist in resolving complex issues, provides judgment and recommendations to manager.
• Assist in defining and documenting departmental procedures and standards including rules of interchangeability, product configurations, product life cycle support and strategic partnership change control.
• Provide customers (internal and external) with technical assistance in Change Control procedures, product structure, configuration management drawing upon knowledge of MRP related issues.
• Build and maintain successful cross functional relationships with internal departments such as R&D, Manufacturing, Quality Control, Regulatory Affairs and Operations.

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

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, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.