C. R. Bard, Inc. Quality Engineer, Post Market Surveillance in Covington, Georgia
The Quality Engineer-Post Market Surveillance is located in Covington, GA at Bard Medical Division.
The Quality Engineer Project Manager for 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/Document Control/Design Control. This includes working to support Design Control projects as well as other duties in support of the Quality System, Design Control System, Document Control, Manufacturing, and the R&D/Product Development departments.
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.
Provides support for Project Teams or Quality Department as required such as generating RFS, ECR, PQR, etc. as required (ie Quality System Documents, Product Documents, Test Methods, Protocols, Process and Product Validations, Stability Protocols, FMEA, FMECA or FTA). as required
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.
Excellent organizational and interpersonal skills.
A strong work ethic and attention to detail.
Strong oral and written communication, analytical skills, and organizational skills.
Ability to communicate at multiple levels of an organization.
Ability to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.
Ability to organize and judge priorities and manage time.
Demonstrated ability to conduct a careful study of data and information in a methodical way
Ability to work in an environment with multiple short-term deadlines, frequent interruptions and changing priorities.
Strong analytic ability is required.
Exceptional people skills; a natural team player with strong leadership skills.
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
Demonstrated skill in driving strategic initiatives
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. May require consultation and direction to complete the essential duties and responsibilities which may require an understands basic applied statistics, knowledge of manufacturing processes, a comprehensive knowledge of quality systems and relationship to business and experience in writing process, software, and equipment protocols/validations and has fundamental knowledge of validation principles.
Ability to interpret Regulations, Corporate, Division and Department Procedures.
Ability to read and comprehend verbal and written instructions. Ability to effectively present information in one-on-one and group situations to supervisor, management and other employees of the organization.
College level mathematical skills.
Basic applied statistics.
Problems will be approached logically and methodically and be able to develop solutions and/or options. Judgment must be made by considering a few important facts. Written rules, precedents, and policies are available for guiding decisions, but are not always easily obtained. Decisions are made frequently, but are rarely needed immediately. As Design Control/ECR work and/or other responsibilities increase, so do the level of complexity and the importance of decision-making..
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.
Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear. May occasionally lift objects up to 25 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Normal office environment - noise level is quiet to moderate - frequent travel is required - when traveling to clinical sites or hospitals, work environment will be specific to the area under evaluation.
Industry Standard/Category: Quality Engineer/Quality Assurance
Career Level: experienced
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.