Sr Analyst, Product Surveillance Quality Assurance

Baxter Healthcare; Tijuana; Presencial; USD 30,000 - 45,000; Jornada completa

Descripción de la vacante

A leading healthcare company in Tijuana is seeking a Post Market Surveillance Quality Associate II. This role involves analyzing complaint information and leading process improvements. The ideal candidate should have a relevant bachelor's degree and at least 2 years of experience in a cGMP environment. Strong communication and problem-solving skills are essential for success in this role.

Formación

• 2+ years relevant work experience in cGMP related industry or in a clinical setting.
• Experience with driving process improvement initiatives preferred.
• Proven knowledge of the FDA Quality System and Regulatory Reporting regulations.

Responsabilidades

• Serve as a subject matter authority for Post Market surveillance processes.
• Analyze Post Market surveillance complaint information to identify issues.
• Lead and/or participate in cross functional continuous improvement activities.

Conocimientos

Strong problem solving

Critical thinking

Analytical skills

Excellent written/verbal communication

Teamwork

Educación

Bachelor’s degree (life sciences preferred)

Descripción del empleo

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.

About Us: Baxter's Mission

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.

Your Role at Baxter

This is where you address challenges to save and sustain lives!

The Post Market Surveillance Quality Associate II is responsible for processing high risk complaint files as well as providing Quality support and oversight. This position also serves as subject matter authority for Post Market surveillance complaint handling process for all US products.

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 global operation.

What you'll be doing

• Serve as a subject matter authority for Post Market surveillance processes such as complaint handling or Regulatory Reporting
• Assisting in handling daily work assignments and workflows, identifying and raising issues
• Analyzing Post Market surveillance complaint information to identify issues or improvement opportunities
• Leading and/or participating in cross functional continuous improvement activities and projects, including NCRs/CAPAs
• Intake of incoming customer calls, and opening complaints from those calls
• Triaging of the Global Corporate Complaints Mailbox
• Timely and accurate processing and disposition of incoming customers’ emails

What you'll bring

• Bachelor’s degree (life sciences preferred)
• 2+ years relevant work experience in cGMP related industry or in a clinical setting.
• Experience with driving process improvement initiatives and projects preferred
• Application of lean principles preferred
• Proven knowledge of the FDA Quality System and Regulatory Reporting regulations (21 CFR 803, 806, 820, and 211)
• Strong customer facing communication with ability to lead people and encourage teamwork
• Ability to drive decisions quickly and effectively
• Excellent written/verbal communication and organizational skills
• Ability to make independent decisions with minimum oversight and ability to work independently
• Strong problem solving, critical thinking and analytical skills

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 click on the link here 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.

Emilio Flores #2471-A|Col. Cañon del Padre|22203 Tijuana, BCN|Mexico