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.
Requirements
- Bachelor's Degree in Engineering required.
- 1-3 years of experience in Design, Operations or Quality.
- Working experience with ISO 13485, MDD, MDSAP, EUMDR Regulations preferred
Responsibilities
- Investigate product quality problems, determine root cause, gather, and analyze data and implement corrective action to reduce or eliminate cause. Drive quality system improvements and ensure compliance to regulatory and procedural requirements. Participate in the improvement of the manufacturing process for existing products. Review and approve work instructions, inspection documents, Bills of Material, and drawings.
- Serve as a primary point of contact for quality related matters. Responsible for leading quality initiatives with operations to improve manufacturing processes and product quality.
- Interface with supplier’s engineering and quality organizations to efficiently address reported problems impacting functionality, quality, and regulatory requirements.
- Work with design engineering to determine receiving inspection requirements of purchased components and finished product. Provide technical quality engineering support to receiving inspection.
- Support operations in trouble-shooting non-conformities to confirm part defects.
- Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, & PQ). Participate in external and internal regulatory compliance inspections and assist in Corrective Action System activities including evaluation of failure investigation and corrective action plans, root cause analysis and follow-up activities.
- Lead the Health Hazard Evaluation activities for the assigned areas.
Other
- Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
- Bachelor's Degree in Engineering required.
- 1-3 years of experience in Design, Operations or Quality.
- Travel requirements not specified
- Must be able to work in a team environment
