Engineering Change Order Analyst

Title: Engineering Change Order Analyst

Location: Milpitas, California

Duration: 1 Month Assignment

Duties:

• This position will focus on integrating Bigfoot Biomedical's Document Control System into Abbott Diabetes Care's quality management system.
• This position will also support archiving records into the corporate regulatory information management system (RIMS).
• Support obsoletion of existing company procedures and replace these procedures with ADC's corporate procedures.
• Conduct work in compliance with regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485).
• Create, analyze, and process Change Items in compliance with QSR, ISO13485, and other applicable standards
• Use Agile or Propel PLM software to improve Document Control processes.
• Participate in project teams to enhance Document Services.
• Support Change Control functions as needed.
• Define and document departmental procedures and standards
• Provide technical assistance in Change Control procedures

Education & Qualification:

• Bachelor’s degree or equivalent combination of education and work experience
• Minimum 4 years relevant experience with a bachelor's degree
• Minimum 7 years relevant experience without a bachelor's degree
• Knowledge of regulations and standards affecting IVDs and Medical Devices
• Experience with document control and change order systems
• Working knowledge of QSR and ISO standards related to document and data control

Soft Skills:

• Attention to Detail: Ensures accuracy and consistency in documentation and training records.
• Communication: Effectively communicates with cross-functional teams.
• Writing: Possesses good writing skills and grammar, as this is critical for reviewing documents and identifying corrections for the document owner.
• Problem-Solving: Identifies and resolves system or process issues proactively.
• Collaboration: Works well with Quality, Regulatory, and Operations teams.
• Adaptability: Responds effectively to changing regulatory requirements and business needs.
• Organizational Skills: Manages multiple priorities.

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