Sr. Analyst, Complaint Hand

Baxter Healthcare; Tijuana; Presencial; MXN 300.000 - 520.000; Jornada completa

Descripción de la vacante

Baxter Healthcare in Mexico is seeking a Sr. Analyst, Complaint Hand to evaluate, process and investigate product complaints for Hill-Rom products to support post-market surveillance.

The Associate Analyst, QA must understand the customer’s allegation and accurately document the summary and investigation details as appropriate. You will work across teams to ensure accurate documentation, timely closure, and compliance with QSR, MDR, and ISO requirements, enabling quality improvements and patient

Formación

• Associate degree or 3+ years in medical devices.
• Proficient in spoken and written English.
• Strong written, verbal, interpersonal, analytical, and organizational skills.
• Experience resolving issues for internal and external customers.
• Able to meet deadlines and manage multiple projects.
• Some exposure to QSR, Medical Device Directive, ISO Quality System.
• Ability to define problems, analyze data, draw conclusions.
• Detail-oriented and accurate.
• Able to work as an individual contributor or in a team.
• Proficient with MS Office; familiarity with EtQ helps.

Responsabilidades

• Leads complaint operations within software applications.
• Handles sequencing of potentially reportable events within software based on risk.
• Ensures complaint records reflect the allegation, investigation and conclusion.
• Works independently and with different parts of the organization to resolve complex issues.
• Requests engineering review to identify root cause for malfunctions.
• Ensures timely closure of complaints to meet regulatory requirements.
• Supports audits by internal corporate, advised bodies, third parties, and regulators.

Conocimientos

Analytical skills

Organizational skills

Interpersonal skills

English (writing/speaking)

Problem solving

Educación

Associate degree

Herramientas

Microsoft Office

EtQ software

Descripción del empleo

This is whereyour 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:

You, as Sr. Analyst, Complaint Hand, will conduct product complaint evaluation, processing, and investigation for Hill-Rom products to support post market surveillance. The Associate Analyst, QA must be able to understand the customer’s allegation and accurately document the summary and investigation details as appropriate.

What you will be doing:

• Leads complaint operations and runs complaints within software applications.
• Handles the sequence and handling of potentially reportable events within software based on an understanding of the risks associated with product malfunction.
• Ensures complaint records accurately reflect the allegation, investigation and conclusion of the customer complaint.
• Works independently and with different parts of the organization to resolve complex issues.
• Identifies the need for and requests engineering investigation reviews to identify the root cause for identified malfunctions.
• Ensures timely closure of complaints to align with regulatory requirements.
• Adapts to changes in the work environment; runs competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events.
• Support internal corporate, advised bodies, third party, and regulatory audits as needed.

What will you bring?

• Associate degree or a minimum of 3 years previous related work experience in the medical device or equivalent combination of education and experience.
• Must be proficient in both speaking and writing in English.
• Good written and verbal skills as well as good interpersonal, analytical and organizational skills.
• Experience in resolving issues for internal and external customers.
• Ability to work within deadlines, and work on multiple projects accurately and efficiently.
• Some experience with QSR, Medical Device Directive, and ISO Quality System.
• Ability to define problems, analyze data, establish facts and draw conclusions.
• Attention to detail and accuracy is required.
• Ability to function as an individual contributor within a team.
• Proficiency with Microsoft Office Products such as Word, Excel or equivalent software. Familiarity with EtQ software is helpful.

Equal Employment 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.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request along with your contact information.