Assoc I Quality Product Surveillance

Baxter International; Gurugram District; Vor Ort; INR 600.000 - 800.000; Vollzeit

Zusammenfassung

Baxter International in Gurgaon, India, seeks an Associate I for Quality Product Surveillance to manage post-market activities, assess product quality issues, and ensure regulatory compliance. The role collaborates with multiple teams to drive timely resolution of complaints and support patient safety initiatives.

The candidate should have 2–3 years in a GMP-regulated environment, an associated degree in a related field, and strong analytical skills.

Qualifikationen

• Experience in a GMP regulated environment such as medical devices or pharma.
• Hands-on experience with complaint handling and regulatory reporting.
• Strong analytical and communication skills for cross-functional collaboration.

Aufgaben

• Manage customer complaints and MDRs across product lines per procedures and regulations.
• Open, document, and maintain complaint records in the system.
• Gather information through follow-up and cross-functional collaboration.
• Evaluate complaints for reportability and support regulatory submissions.
• Assist investigations, product evaluations, and sample retrieval.
• Communicate status and resolution to customers in writing and verbally.
• Ensure timely closure of records per procedures and quality requirements.
• Monitor workflow, raise concerns, and coordinate internal/external communications.
• Participate in continuous improvement initiatives and quality projects.
• Provide guidance and mentorship to junior team members when needed.

Kenntnisse

GMP experience

Quality assurance

Regulatory knowledge

Analytical skills

Ausbildung

Associate’s degree in nursing or related

Bachelor’s degree preferred

Tools

Complaint management systems

Jobbeschreibung

This is whereyour 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 elevate 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.

Baxter (India) Pvt. Ltd 5th Floor,Tower,' A, Building No.9, DLF Cyber City, DLF Phase - III|Gurgaon- 122002|Haryāna|India