Assoc I Quality Product Surveillance

Overview

Supports post-market surveillance by managing customer complaints, assessing product quality issues, and ensuring compliance with regulatory and quality requirements, working cross-functionally to investigate concerns and drive timely complaint resolution.

What you'll do

• 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 you'll need

• 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; equivalent industry experience may be considered.
• 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.

Nice to have

• Bachelor's degree and/or clinical certifications such as Medical Technologist, Medical Laboratory Technician, Licensed Practical Nurse, or Registered Nurse.
• Project Management experience and/or certification.

Details

• Night-shift schedule to support business operations across global time zones.