At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward.
As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world.
To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards.
We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.What You Can ExpectThe purpose of this position is to complete data analysis, reports, and trending of data for the Post Market Surveillance function .
The role will be responsible for analysis, data dissemination, and follow-up on identified patterns in the data.
.
As such, the incumbent must 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 will be key for this role.How You'll Create Impact Develops and maintains tools for capture, analysis, and tracking of complaint data.Support activities for complaint processing, such as technical investigation, review, regulatory reporting (MDR, MDV).Assists sites with response plans to FDA and Notified Body (NB) audit findingsCollaborates with Corporate Quality staff in capture and analysis of findings for KPI metrics and Management Review Proactively works to ensure that quality systems and processes across Zimmer are effective and compliant to all applicable Post Market regulations and standards.What Makes You Stand Out Possesses a broad business perspective, including understanding of Zimmer business structure and product realization processes across the enterprise Must work well with others and interact effectively with all organizational levels, outside contacts and support personnel.
Must be creative in solving problems and assisting sites with developing effective corrective action plans.
Must possess an in depth understanding of GxP regulations, Post Market Surveillance and reporting regulations, and the function of quality systems Must be able to effectively communicate in both oral and written formats.
Your Background Bachelor's degree in an appropriate engineering, technical, or healthcare discipline, or bachelor degree with relevant experience Knowledgeable of FDA regulations and applicable ISO standards.
5-7 years plus quality or regulatory work experience in an FDA regulated industry required.
Previous experience in a Post Market Surveillance role a plus.
Travel Expectations Up to 20% travel required (domestic and international) EOE/M/F/Vet/Disability