Title: Engineering Change Order Analyst
Location: Alameda, CA
Duration: 12 Months
Requirements for the role:
- A change analyst with a strong understanding of the Change Control process in a Product Lifecycle Management (PLM) system and Document Management System (DMS) (Oracle Agile strongly preferred) to administer and implement changes related to products/materials, documents, and quality records according to CFR Part 820 and ISO13485.
- Experience in processing items in the PLM/DMS for End of Life of products or obsolescence of parts/documents
- Strong understanding of BOM structure and changes.
- Comfortable to interact and collaborate with cross-functional groups or SMEs to address any challenges preventing a change from being processed.
- Can efficiently manage priorities as large volumes of changes and documents are being submitted to meet aggressive and tight timelines.
- Understanding of GDP and cGMP.
List any preferred requirements that would stand out on a resume:
- Experience with processing changes packages for QA/QS in PLM/DMS such as Agile, Windshield, Propel, Veeva, etc.
- Knowledge of industry regulations and standards such as ISO13485, 21 CFR Part 820, 21 CFR Part 11, EU MDR, and IVDRR.
- Proficient in MS Office.
- Ability to multi-task in a fast-paced environment.
List Top 3 Skills you are looking for:
- Strong organizational skills
- Work independently
- Very Highly detail oriented
Years’ of experience required:
- 4+ Years
Required education level/certifications:
- Bachelor’s degree with 4 years of experience preferred or High School diploma with minimum of 7 years of experience required
Description of work environment/department:
- Collaborative
- Open communication
- Fast pace
- High demand
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.