Quality Assurance Specialist (1 Year Contract)

Quality Assurance Specialist (1 Year Contract)

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. Key Responsibilities

Product Complaint Related Matter / Non-Conformance / Product Recalls / FAs / Hold : responsible for complaint-related processes and ensure procedure compliance. Complete Product Complaint reporting to notify the Complaint Coordinator within the required timeframe and investigate returned samples to determine root cause. Report, follow up, and trend product complaints. Support completion of customer acknowledgement for Field Action (FA), the closure document, and filing. Reply to customer complaints and queries related to quality; prepare any recall or Field Action documentation as needed. Perform Hold activities within the required timeframe. Quality Operations : redress instructions and file dispositions; release Finished Goods with appropriate temperature control after routine redressing; manage Product Return dispositions; support distribution operations. Document Management : document control and maintenance of records (retention) to ensure compliance with regulatory requirements, GDP, and SOPs; assist with SOP preparation, Document Change Requests (DCRs), and Periodic Review. Internal Requirements and Improvements : ensure compliance with SOPs, quality assurance standards, internal and local regulations, and GDPMDS / GDPMD Standards; assist with data gathering and analysis for Quality Review / Complaint to ensure it occurs at the required frequency. Support in external and internal audits; regulatory reporting determination. Review complaints for overseas reporting requirements regionally and assist country QA in obtaining required documentation for reporting. Perform other duties as assigned. Requirements

At least 3 years of relevant experience in medical devices, pharmaceutical and biologics. Quality experience within a healthcare environment. Regional experience will be an advantage. Familiarity with Quality systems. Good understanding of GDPMD. Able to work independently with little supervision. Good sense of urgency and strong follow-up. Ability to multitask and prioritize. Interpersonal and communication skills. Technical system skills (e.g., word processing, spreadsheets, databases, online research). Ability to identify compliance risks and escalate when necessary. 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 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. Seniority level

Mid-Senior level Employment type

Full-time Job function

Quality Assurance Industries

Medical Equipment Manufacturing Pharmaceutical Manufacturing Hospitals and Health Care We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

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