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Job Description
Job Summary
The Post-Market Quality Administrator supports the Becton Dickinson ) Post-Market Quality team by managing and processing post-market quality data, ensuring compliance with regulatory requirements and internal procedures for medical devices.
Job Responsibilities
Process and manage post-market quality records, including Situation Analysis, Health Risk Assessments and Field Action Committees, within established timelines.
Accurately record and maintain detailed documentation of all post-market quality activities in relevant databases and systems.
Support the regional PMQ teams in executing field actions by gathering necessary information, retrieving relevant records, and coordinating with other departments as required.
Generate routine reports on post-market quality data, trends, and key performance indicators.
Maintain and update post-market quality procedures and work instructions to ensure ongoing compliance.
Assist in preparing for internal and external audits by compiling documentation and providing administrative support.
Collaborate with cross-functional teams, including R&D, manufacturing, regulatory affairs, and customer service, to address quality issues.
Participate in continuous improvement initiatives related to post-market surveillance processes.
Adhere to all company policies, procedures, and relevant medical device regulations (e.g., MDR, FDA QSR).
Job Qualifications
Minimum of 2 years of experience in a quality assurance or administrative role within the medical device or pharmaceutical industry.
Strong understanding of quality management systems (e.g., ISO 13485) and medical device regulations.
Proficient in using quality management software and enterprise resource planning (ERP) systems.
Excellent data entry skills and attention to detail.
Strong organizational and time management abilities, with the capacity to manage multiple tasks concurrently.
Effective written and verbal communication skills.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
Ability to work independently and as part of a team.
A Levels or equivalent qualification in a science-related field or relevant experience.