Assoc I Quality Product Surveillance

4103 BAXTER INOV & BUS SOL PRVT LTD; Gurugram District; Vor Ort; INR 700.000 - 900.000; Vollzeit

Zusammenfassung

Baxter is seeking an Associate I, Quality Product Surveillance to support post-market surveillance, manage customer complaints, assess product quality, and ensure regulatory compliance. The role collaborates with cross-functional teams to investigate concerns and drive timely resolutions.

This position emphasizes patient safety and continuous improvement, involves night shift to support global operations, and offers opportunities to mentor others while contributing to quality programs.

Qualifikationen

• 2–3 years of experience in a CGMP-regulated industry, medical device, pharmaceutical, healthcare, or clinical setting.
• Associate’s degree in nursing, Pharmacy, Medical Technology, Engineering, Life Sciences, or related scientific discipline.
• Bachelor’s degree and/or clinical certifications such as Medical Technologist, Medical Laboratory Technician, Licensed Practical Nurse, or Registered Nurse preferred.

Aufgaben

• Manage and process customer complaints and 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 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.

Kenntnisse

Communication skills

Customer service

Interpersonal skills

Analytical thinking

Problem solving

Cross-functional collaboration

Ausbildung

Associate degree in nursing

Bachelor's degree

Medical Technologist

Medical Laboratory Technician

Licensed Practical Nurse

Registered Nurse

Jobbeschreibung

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. 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 ...
• 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.

No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives. Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.