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About the Role
At Baxter, we are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.
Responsibilities
- Perform the inspection of DHR documentation for devices and modules to ensure test procedures have been completed and release specifications are within specifications for final device acceptance and release.
- Perform internal inspection of devices to ensure all visual aspects of the device or module, including approved labels, are met prior to release.
- Verify that all customer facing device and packing labels are accurate and match the serial number being inspected.
- Approve the release of the device and module in the appropriate ERP system.
- Ensure there are no open nonconformances associated with the device or module in the approved NCR system (SAP).
- Review the event history log within a device to ensure values have been accurately entered in the required testing values or results recorded in the DHR.
- Accurately record all failing observations using the minor correction process and/or electronic nonconformance system.
- Disposition rework activities of nonconformances and complete the electronic approval and closure process for any non-conformances with the device.
- Ensure process control and maintenance procedures are being followed.
- Recognize out of compliance/out of tolerance situations and take appropriate action.
- Add QA flags to all received product using the appropriate ERP system.
- Inspect and perform QA release activities of Spare Parts Kits.
- Assist with identification and containment of nonconforming product on the floor for internal investigations and holds.
- Perform other duties as assigned.
Requirements
- Knowledge and working application of measurement equipment.
- Knowledge and working application of cGMP documentation and FDA.
- Knowledge and working application of Basic ESD requirements.
- Knowledge and working application of Computer based programs.
- Knowledge and working application of Data entry and spreadsheet applications.
- Perform repetitive motions with hands/fingers.
- Demonstrated attention to details and accuracy.
- Must have good communication skills.
- May be required to work flexible hours and overtime on short notice.
- Ability to visually inspect and identify particulate/foreign matter and distinguish between colors as required by FDA Current Good Manufacturing Practices.
- Must be able to sit for most of the work day.
- Ability to stand or walk for long periods.
- Must have good hand to eye coordination and dexterity.
- Must have the ability to lift and carry 23 pounds.
- Must have the capability to push and pull a maximum force of 5 pounds 4 feet.
Skills
- Data entry
- Spreadsheet applications
- Communication skills
- Visual inspection
- Attention to detail
- Accuracy
Location
- USA
Work Type
- Full-time
Experience Level
- Not specified
Education Level
- High school diploma or GED
Benefits
- 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) with the ability to purchase company stock at a discount
- 401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching
- Flexible Spending Accounts
- Educational assistance programs
- Paid time off ranging from 20 to 35 days based on length of service
- Family and medical leaves of absence
- Paid parental leave
- Commuting benefits
- Employee Discount Program
- Employee Assistance Program (EAP)
- Childcare benefits
About the Company
- At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
- Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration.
- This is a manufacturing environment regulated by the FDA.
Equal Opportunity
- Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
- Know Your Rights: Workplace Discrimination is Illegal
- Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally.
- Recruitment Fraud Notice