This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives-where your purpose accelerates our mission.
DUTIES AND RESPONSIBILITIES:
- Approval of new parts, supplier of raw material and services assuring full compliance with Corporate Division, FDA and other applicable regulations.
- Works closely with suppliers and buyers as appropriate in the resolution of supplier quality concerns. Initiate and follow up SCAR’s and ICAR’s.
- Implement Quality Culture Initiative at Supplier Facilities (ICare-Supplier)
- Implement and Monitor Interplant Process Review for Critical Suppliers
- Assist the Quality Superintendent in the evaluation and decisions toward the acceptability or rejections of product.
- Provide support to product/process transfer projects to assure compliance with procedures, as well as facilitation of activities required in the transfer.
- Develop and support continuous improvement activities to enhance the Quality Systems, using a variety of Quality and Continuous Process Improvement tools; including but not limited to Six Sigma, Kaizen lean methods, etc.
- Assure monthly Supplier and Incoming quality indicators and quarterly Quality Systems Management trends reviews are to identify areas for opportunities, both for productivity and quality improvements, supporting our facility quality improvements processes.
- Assure weekly follow up and reports for the Incoming Work in Progress (WIP), and the Quarantine Inventory of Non-conforming material, in order to maintain the adequate level of information for action needed.
- Work with Improvement Projects for the Supplier Quality System.
- Supervise incoming inspection operations regarding raw material related inspection, issues and receiving.
- Ensure that personnel under his/her supervision are trained and know the risks and environmental aspects of the area.
- Lead supplier’s performance evaluations, along with Purchasing Area.
- Maintain fluid conversation with suppliers in order to correct opportunities found and to improve alignment of requirements and expectations in order to minimize financial impact due to lack of raw material and regulatory.
- Analyzed and lead raw material to be included in Certification Program and Lot Monitoring.
- Received Maintenance request records and perform them into the POM’s Program.
- Lead Internal Audits.
- Lead special projects on related duties.
- Learn and practice basic ergonomic principles to reduce job-related discomfort and injuries.
- Observes all company and regulatory EHS requirements.
- Be knowledgeable of all the associated risks and environmental aspects of his/her area and support the identification of new risks.
EDUCATION AND/OR EXPERIENCE:
- BS Degree in Science, Engineering or related discipline.
- Supplier Quality Professional Certification (Preferred)
- 5 years of experience in Medical Device Industry, preferably in Quality areas
- Experience working with suppliers, in preferred.
- Knowledge on Good Documentation Practices, Good Manufacturing Practices, Quality System Regulations, Sampling Techniques, Good Writing Techniques.
- Microsoft (Word, Power Point and Excel).
- ISO 9001 and ISO 13485 requirements.
- Self-starter individual capable of working alone with full understanding of quality measurements.
- Good interpersonal skills.
- Ability to assess potential risk issues and relate them to the intended use of the product or service being evaluated.
- Willing to travel, as requested.
- Bilingual (English and Spanish)
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.