Job Title: Quality Professional
Company: Abbott Rapid Diagnostics (ARDx)
Location: Global
Description:
We are seeking a Quality Professional to support the implementation and maintenance of our post-market surveillance reporting to meet the requirements for the In-Vitro Diagnostics Regulation (IVDR) into our Quality System.
The successful candidate will lead activities assigned to them, collating needed inputs for reporting, working collaboratively with a broad cross-functional team.
Responsibilities:
* Carrries out duties in compliance with established business policies and procedures.
* Demonstrates commitment to the development, implementation, and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
* Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
* Understands and maintains awareness of the quality consequences which may occur from the improper performance of their specific job.
* Perform other duties and projects as assigned.
* SUPPORTS THE IMPLEMENTATION AND MAINTENANCE OF THE EFFECTIVENESS OF THE QUALITY SYSTEM WITH RESPECT TO COLLATION OF DATA AND GENERATION OF REPORTS REQUIRED TO SUPPORT POST MARKET SURVEILLANCE REPORTING SUBMISSIONS, AS ASSIGNED.
* Works collaboratively with a global cross-functional team to revise existing or establish new quality system requirements/processes, procedures, and report templates compliant with the new regulation with respect to post-market surveillance reporting.
* Uses critical thinking to provide solutions that are compliant, innovative, and consistent with organizational objectives.
* Coordinates and leads the assigned schedule associated with the accrual, assembly of post-market surveillance inputs ensuring accurate and timely submission.
* SUPPORTS THE PROCESSES FOR ACQUIRING, MANAGING, ANALYZING, INTERPRETING, AND REPORTING POST MARKET SURVEILLANCE DATA NECESSARY TO SUPPORT PMS REPORTS SUCH AS PERIODIC SAFETY UPDATE REPORT (PSUR), POST MARKET PERFORMANCE FOLLOW-UP (PMPF), POST MARKET CLINICAL FOLLOW-UP (PMCF), CLINICAL EVALUATION REPORT (CER) AND RELATED REPORTS ALONG WITH SUPPORTING THE MAINTENANCE OF APPROPRIATE DESIGN HISTORY FILE (DHF) DOCUMENTS SUCH AS RISK MANAGEMENT FILES (RMF).
* Partners with Vigilance, Regulatory Affairs, Clinical Affairs, product, instrument, and software teams, Field Assurance, Marketing, and manufacturing facilities to proactively plan for and complete PMS reports, ensuring needed data is gathered accordingly.
* Elevates and articulates concerns to management in a timely manner, proposing solutions and leading change as needed.
* As a post-market surveillance reporting subject matter expert, supports audits and additional information request inquiries relating to post-market surveillance reporting.
Requirements:
* Bachelor's degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.
* At least 3 year's work experience in a related field experience; less experience may be appropriate with advance degree.
Benefits:
Abbott welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities.