BD Urology and Critical Care a BD Company is seeking to fill the position of Quality Engineer, Post Market Surveillance in Covington, GA. Formerly Bard Medical we are in the business of advancing lives and the delivery of healthcare.
The Quality Engineer Post-Market Surveillance is primarily responsible for executing and coordinating the day-to-day operations of the division’s post-market surveillance programs and related activities.
Additionally, this position performs various quality-engineering functions and associated support tasks in developing knowledge and experience in the areas of Quality Assurance/Design Control. This includes working to support Design Control projects as well as other duties in support of the Quality System, Manufacturing, and the R&D/Product Development departments.
ESSENTIAL JOB FUNCTIONS:
Ensure that division post-market surveillance activities are completed on-time and in compliance with applicable regulations and company procedures.
Maintain accurate documentation and files related to Post Market Surveillance Reviews and schedule.
Interact directly with Regulatory, Clinical, Marketing, Manufacturing, R&D, and Quality Assurance, as needed, during the course of Post Market Surveillance Review process and builds productive cross functional working relationships.
Excels at generating and maintaining organized and accurate records; PC skill, word processing, spreadsheet, database.
Builds productive working relationships.
Escalates issues to manager for resolution, as deemed necessary.
In addition, position maintains and implements changes to existing Post Market Surveillance
Ensures compliance to Department and Division procedures.
Represents the Corporation, Division and Quality Department in a professional manner.
Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner.
Travels as required by the above duties and responsibilities.
Must be able to drive multiple assigned projects at both the strategic and tactical levels.
A positive, proactive attitude with a logical, data driven approach to problem solving.
Ability to participate on teams and maintain positive work environment with those teams.
Proven ability to coach and influence others in a respectful way.
Able to influence change without direct authority
Must work with a sense of ownership and accountability and be driven to achieve results.
Ability to understand the functionality / intended use of complex medical devices.
Basic knowledge of medical devices, their development and quality control
Understands Basic Fundamentals of Engineering Principles
Proficient in the use of project management tools, and application of continuous process improvement methodologies such as Six Sigma
Demonstrated problem solving and critical thinking ability
Thorough working knowledge of Medical Device Industry Product Risk Management Regulations and Standards
A fundamental working knowledge of ISO, FDA, cGMP regulations
Ability to perform detailed engineering work under direction of a Senior Engineer or Quality Management.
Ability to interpret Regulations, Corporate, Division and Department Procedures.
Exceptional people skills; a natural team player with strong leadership skills.
Strong oral and written communication, analytical skills, organizational skills and attention to detail.
BS. in Engineering, Engineering Technology, Science a minimum.
American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred.
Minimum 5 years of experience with FDA regulated industry.
Prior experience processing medical device or drug complaints strongly preferred.
About BD / CR Bard
BD Urology and Critical Care is currently hiring a Quality Engineers, Risk Management, Post Market Programs, & Quality Engineer I(s). These positions are a growth opportunity based in Covington, GA. Formerly Bard Medical, we have joined Becton-Dickinson a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care.