02 ago
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Baxter
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Tijuana
**This is where**your work makes a difference.
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. 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.
**This is where your work makes a difference.**:
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. 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.
**Your Role at Baxter**
The Compliance Quality Associate is responsible for identifying, assessing, and driving actions to correct regulatory and quality risks within complaint records, to ensure compliance and congruency of complaint records across Regions and Segments.
This position serves as a Subject Matter Expert for Postmarket surveillance processes such as complaint handling and Regulatory Reporting. This role is also responsible for process and tools needed to ensure compliance and for driving actions/corrections to the complaint records.
Ability to handle multiple projects and demonstrate effectiveness in task completion, decision-making, empowerment of others, problem solving and leadership. A strong understanding of the complaint management system, procedures, FDA, ISO and Baxter Quality systems is also required.
**Your Team at Baxter**:
Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our general operation.
The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.
The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate.
As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.
We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.
**What you'll be doing**:
- Serves as a Subject Matter Expert for complaint handling and Regulatory Reporting
- Establishing and maintaining processes and automation tools to ensure compliance and congruence of complaint records
- Monitoring output of the automated tools and proactively identifying potential congruency or accuracy issues within complaint records
- Ensuring corrections are made in a timely manner and monitoring results of the corrections and actions
- Effectively identifying improvements and leading continuous improvement efforts and projects, including NCRs/CAPAs
- Leading audit readiness activities and efforts for Postmarket Surveillance function, including potential r_isk identification, mitigations, and improvements_
- Participating in external and internal Audits as a complaint process Subject Matter Expert, including direct interactions with the Auditor(s), providing support to Audit requests, providing support to responses, and driving completion of Audit commitments
- Maintaining a high level of expertise in current regulatory requirements
- Writing, reviewing, and revising written Procedures and submitting procedural changes a
📌 Quality Associate (Tijuana)
🏢 Baxter
📍 Tijuana