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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
Revise and approve all documentation related to areas of responsibilities such as In Process Checker Charts, Product Retention Records, Control Charts, Mold Approvals, Batch Records and others
Responsible for routine manufacturing audits of machine parameter and/or set-ups for compliance as well as the product manufactured
Perform routine audits of sampling techniques testing skills and all documentation performed by the TIQ's
Responsible for immediate notification and awareness to Quality Management of potential Quality situations
Assist and coordinate protocols
Provide training as required on Good Documentation Practices, SPC, Total Integrated Quality and others
Provide support regarding mold approval and mold start up evaluations
Gather, analyze, audit and interpret data using SPC methods to predict trends and recommend process improvements
Insure that all machinery, equipment, tools or any other measuring, monitoring material complies with Corporate, GMP and other regulatory requirements
On a monthly basis publish Quality Indicators including DPM’s, Pareto Analysis on responsibility areas
Submit improvements and/or modifications to specifications and Standard Operating Procedures
Maintain good timely communication and awareness on DPM and complaints trends with internal and external customers/suppliers
Assist in the development / certification of the TIQ’s
Perform special projects related to responsibility areas
Manually document and/or electronically the required information to comply applicable procedures and specifications
Observe all company and regulatory EHS requirements
Observe data privacy policies at all time
Provide support on Software application audits execution
Assist on the generation and investigation of non-conformities
Requirements
Bachelor Degree Science
At least two years of experience dealing with related job on Medical Device Industry
Knowledge in Data Entry – Microsoft Office Software
Basic computer knowledge is required
Experience in measurements instrumentation
Good interpersonal skills
Willing to travel occasionally
English & Spanish
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 starting 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