USA - Global Product Surveillance Quality Associate II- K...

Job Description

Job DescriptionWe are looking for a Global Product Surveillance Quality Associate II to join our team in Medina, New York. This position involves handling product complaints, triaging incoming issues, and ensuring compliance with quality standards and regulations. As a long-term contract role, this opportunity offers the chance to contribute to continuous improvement initiatives while collaborating with cross-functional teams.

Responsibilities:
• Triage incoming complaints from customers to assess risk and determine next steps.
• Gather and document all necessary information for complaint investigations.
• Evaluate the reportability of complaints in alignment with regulatory requirements.
• Draft technical investigation response letters to address customer concerns.
• Participate in improvement projects, including product enhancement initiatives.
• Lead projects as assigned and provide technical approval when required.
• Manage workflow effectively, identifying and escalating issues as needed.
• Mentor and train team members in product surveillance processes.
• Ensure compliance with regulations and standard operating procedures through diligent oversight.• Strong knowledge of quality systems and medical device reporting regulations such as 21 CFR 803, 806, 820, and 211.
• Familiarity with product usage and manufacturing processes for assigned products.
• Exceptional technical writing skills for drafting investigation reports and customer response letters.
• Ability to prioritize tasks and manage multiple projects with minimal supervision.
• Excellent communication and organizational skills to facilitate effective collaboration.
• Proficiency in computer systems for word processing, data analysis, and complaint management.
• Bachelor’s degree required, with 2-5 years of relevant experience in a cGMP-related industry or clinical setting.
• Demonstrated problem-solving and analytical abilities to support decision-making.