Abbott Business Analyst - Structural Heart in St. Paul, Minnesota
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 107,000 colleagues serve people in more than 160 countries
Structural Heart Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.
WHAT YOU’LL DO
To support product change control while ensuring conformance to applicable Abbott Quality System (QS) requirements. Subject matter expert for Product Lifecycle Management (PLM) system and its interaction with the Enterprise Resource Planning (ERP) system as it relates to product change control.
Common decisions this role will make:
• The scope and structure of complex change orders
• When and how to communicate the status of change orders and implementation schedules to cross-functional, cross-site team members and managers
• When and how to escalate issues to Operations and cross-site, cross-functional management
Perform tasks that drive the timely release, approval and revision of product documentation and supporting data throughout the product's lifecycle. (50%)
Scope and structure change requests and change orders for new finished goods, semi-finished goods and parts to ensure timely and efficient cross-functional, cross-site review and approval.
Write change requests and change orders in compliance with Quality System requirements.
Drive the timely cross-functional, cross-site review and approval of change orders through clear and concise verbal and written communication.
Collaborate with remote and local manufacturing sites, Supply Chain and Regulatory Affairs to prioritize and schedule the implementation of approved change orders to ensure continuity of manufacturing & distribution.
As Product Lifecyle Management (PLM) Subject Matter Expert (SME), provide technical support to across manufacturing sites to troubleshoot PLM problems and provide solutions.
These tasks will come from
Supplier change requests
Regulatory requirement changes
Business initiatives (e.g., cost improvement projects)
Evaluate and process electronic change requests and change orders in adherence to QS procedures. (20%). These will be evaluated against:
Quality System (QS) Standard Operating Procedures (SOPs)
Work Instructions (WIs)
Implementation of changes such that the continuity of manufacturing & distribution are not affected
Participate in or lead special projects, including recommending PLM or other process improvements. (20%)
Apply best practices of change control and configuration management. (5%)
Provide detailed reports, queries or summaries in support of various cross-functional projects and initiatives (5%)
EDUCATION AND EXPERIENCE YOU’LL BRING
- Bachelors Degree (± 16 years)or equivalent years of experience
Minimum 4 years
Work experience in engineering, operations management, management information systems or data sciences and working knowledge of product configuration management principles.
Working knowledge of quality systems, compliance and change control requirements in a regulated industry is required.
Detail-oriented and self-directed with good time management skills.
Ability to work independently and collaborate across functions or as part of a cross-functional team.
Excellent critical thinking skills & ability to identify and solve problems of moderate scope & complexity.
Working knowledge of Microsoft Excel, Word, Outlook and PowerPoint.
- Working knowledge of PLM is preferred.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
Training and career development , with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
*Learn more about our benefits that add real value to your life to help you live fully: * www.abbottbenefits.com at http://www.abbottbenefits.com/pages/candidate.aspx
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com at http://www.abbott.com/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
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