Product Surveillance Quality Associate I

4 weeks ago

Gurgaon, India BAXTER Full time

**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.

**Your role at Baxter**:
This position is responsible for processing complaint files and/or Regulatory Reports

**Essential Duties and Responsibilities**:

- Effectively manage and process complaints, which includes performing daily tasks associated with processing complaint files across multiple product lines, which may include:

- Opening complaint records.
- Collecting necessary complaint information.
- Performing follow-up with the customer (written and verbal).
- Determining reportability of complaints.
- Evaluating complaints for need to investigate and coordinating sample retrieval.
- Responding to customer complaints (written and verbal).
- Timely closure of complaints, as per procedure.
- Effectively manage and process MDRs (Medical Device Reports) and more complex complaints under supervision
- Effectively manage workflow, identifying and escalating issues.
- Triaging internal and external communication for complaints.
- May participate in continuous improvement efforts and projects, as assigned.

**Skills: -**
- Fluent in English: solid written and verbal communication skills.
- Ability to prioritize and multitask.
- Proficient with computers.
- Ability to work with cross-functional teams to interact effectively with peers, management, and customers.
- Readily accepting of assignments to new/different products.
- Strong critical thinking and problem-solving skills.
- Ability to work independently.
- Detail oriented

**Education and/or Experience**
- Minimum of an Associate’s Degree required in nursing, pharmacy, medical technology, engineering or scientific background MLT (Medical Laboratory Technician), LPN- Licensed Practical Nurse, RN-Registered Nurse or equivalent experience (defined as a minimum of 1 year of medical products industry experience). Bachelor’s degree and/or clinical certification (MT, RN) preferred
- 0-1 year work experience in a cGMP(Current Good Manufacturing Practice) related industry or in a clinical setting
- Project Management experience and/or certification preferred

**Reasonable Accommodations**

**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.

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