Assoc I Quality Product Surveillance

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Your Role

at Baxter The Associate I, Quality Product Surveillance supports post-market surveillance activities by managing customer complaints, assessing product quality issues, and ensuring compliance with regulatory and quality requirements. This role collaborates with cross-functional teams to investigate product concerns, support regulatory reporting, and drive timely resolution of complaints.

We are seeking a detail-oriented professional with strong analytical and communication skills who is passionate about patient safety, product quality, and continuous improvement. What will you be doing Manage and process customer complaints and Medical Device Reports (MDRs) across multiple product lines in accordance with company procedures and regulatory requirements.

Open, document, and maintain complaint records in complaint management systems. Gather and assess complaint information through customer follow-up and cross-functional collaboration. Evaluate complaints for reportability and prepare regulatory submissions, including MDRs, as required. Support complaint investigations, product evaluations, and sample retrieval activities.

Communicate with customers regarding complaint status and resolution through verbal and written correspondence. Ensure timely completion and closure of complaint records in compliance with established procedures and quality requirements. Monitor workflow, identify issues, and escalate concerns appropriately. Coordinate internal and external communications related to complaint handling activities.

Participate in continuous improvement initiatives and quality projects. Provide guidance, training, and mentorship to less experienced team members when required. What will you bring 2-3 years of experience in a Current Good Manufacturing Practices regulated industry, medical device, pharmaceutical, healthcare, or clinical setting.

Associate’s degree in nursing, Pharmacy, Medical Technology, Engineering, Life Sciences, or a related scientific discipline required. Bachelor's degree and/or clinical certifications such as Medical Technologist, Medical Laboratory Technician, Licensed Practical Nurse, or Registered Nurse preferred. Equivalent industry experience may be considered.

The role follows a night-shift schedule to support business operations across global time zones. Project Management experience and/or certification preferred. Strong communication, customer service, and interpersonal skills with the ability to collaborate effectively across cross-functional teams, customers, and stakeholders.

Detail-oriented self-starter with strong analytical, critical thinking, problem-solving, prioritization, and multitasking skills; able to work independently in a fast-paced environment and adapt to new products and responsibilities. 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.

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