Quality Compliance Senior Analyst

hace 1 mes


Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completo
About the Role

At Zimmer Biomet, we're dedicated to pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader, we're committed to enhancing patient mobility and renewing life for people worldwide.

As a key member of our team, you'll be part of our commitment to providing development opportunities, robust employee resource groups, a flexible working environment, competitive total rewards, wellness incentives, and a culture of recognition and performance awards. We strive to create an environment where every team member feels inspired, invested, cared for, valued, and has a strong sense of belonging.

Key Responsibilities

This role involves completing data analysis, reports, and trending for the Post Market Surveillance function. You'll be responsible for analysis, data dissemination, and follow-up on identified patterns in the data. To excel in this position, you'll need to be knowledgeable in multiple regulatory schema and possess technical understanding of information technology, quality, and GxP processes. In-depth knowledge of Post Market processes, including complaint handling, regulatory reporting, and technical investigation, is essential.

Impact and Expectations

As a member of our team, you'll develop and maintain tools for capture, analysis, and tracking of complaint data. You'll support activities for complaint processing, such as technical investigation, review, and regulatory reporting. You'll also assist sites with response plans to FDA and Notified Body audit findings and collaborate with Corporate Quality staff in capture and analysis of findings for KPI metrics and Management Review. Additionally, you'll proactively work to ensure that quality systems and processes across Zimmer are effective and compliant to all applicable Post Market regulations and standards.

Requirements

To succeed in this role, you'll need a broad business perspective, including understanding of Zimmer's business structure and product realization processes across the enterprise. You'll work well with others and interact effectively with all organizational levels, outside contacts, and support personnel. You'll be creative in solving problems and assisting sites with developing effective corrective action plans. You'll also possess an in-depth understanding of GxP regulations, Post Market Surveillance, and reporting regulations, as well as the function of quality systems. Effective communication in both oral and written formats is essential.

Education and Experience

A Bachelor's degree in an appropriate engineering, technical, or healthcare discipline, or a Bachelor's degree with relevant experience, is required. You'll need knowledge of FDA regulations and applicable ISO standards. A minimum of 5-7 years of quality or regulatory work experience in an FDA-regulated industry is required, with previous experience in a Post Market Surveillance role being a plus. Up to 20% travel may be required (domestic and international).

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