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This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.
Job Responsibility:
Ensure the Device History Records (DHRs) are properly and accurately completed
Verify required documentation for entering DHRs into the Document Control System
Respond to and fulfill internal and external DHR requests, ensuring accuracy, completeness, and timely turnaround
Maintain accurate document control practices in accordance with internal quality system requirements
Manage document retention activities, ensuring controlled records are stored, archived, and retrievable per regulatory and company standards
Act as a liaison to offsite document control storage sites, coordinating transfers, retrievals, and audits
Perform Periodic Document Reviews (PDRs) for Job Instructions (JIs), ensuring documents remain current and compliant
Execute responsibilities as a Document Control Change Analyst, including review, routing, and processing of document change requests (DCRs)
Support internal and external audit activities by providing accurate documentation and records
Capable of performing complex or non-routine tasks requiring deep understanding of quality processes
Collaborate cross-functionally with manufacturing, engineering, and quality teams to resolve issues and support continuous improvement
Train peers or team members as needed on procedures or documentation processes
Lead and participate in cross-training initiatives to build team capability and ensure coverage across all Quality functions
Requirements:
High school diploma or GED
Strong organizational/documentation skills
Microsoft Excel experience
Demonstrated high attention to detail
Nice to have:
4-year technical degree or equivalent work experience
Agile and or JD Edwards experience
What we offer:
Support for Parents
Continuing Education/Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service