Sr Analyst, Product Surveillance Quality Assurance

Welch Allyn Servicios MEX; Tijuana; Presencial; MXN 732,000 - 1,100,000; Jornada completa

Descripción de la vacante

A global healthcare company in Tijuana seeks a Post Market Surveillance Quality Associate II responsible for processing high-risk complaint files and providing Quality support. Candidates should have a bachelor's degree in life sciences and 2 years of relevant experience. The role emphasizes process improvement and compliance with FDA regulations, and offers full-time employment with competitive benefits.

Formación

• 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 and 211).
• Strong customer facing communication with ability to lead people and encourage teamwork.
• Excellent written / verbal communication and organizational skills.
• Strong problem solving, critical thinking and analytical skills.

Responsabilidades

• Serve as a subject matter authority for Post Market surveillance processes.
• Assist in handling daily work assignments and workflows.
• Analyze Post Market surveillance complaint information to identify issues.
• Lead and participate in cross functional continuous improvement activities and projects.
• Intake of incoming customer calls and opening complaints from those calls.
• Timely and accurate processing of incoming customer emails.

Conocimientos

Test Cases

SQL

Quality Assurance

Agile

TFS

Jira

Software Testing

Test Automation

Cucumber

QA / QC

SDLC

Selenium

Educación

Bachelors degree (life sciences preferred)

Descripción del empleo

This is where your work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou will find purpose and pride.

About Us : Baxters 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. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.

Baxters 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 liveswhere your purpose accelerates our mission.

Your Role at Baxter

The Post Market Surveillance Quality Associate II

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

This position 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 its 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 youll 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 youll bring

• Bachelors 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 CFRand 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.

Required Experience :

Senior IC

Key Skills

Test Cases,SQL,Quality Assurance,Agile,TFS,Jira,Software Testing,Test Automation,Cucumber,QA / QC,SDLC,Selenium

Employment Type :

Full-Time

Experience :

years

Vacancy :

1