The Sr. Quality Engineer position is located at C. R. Bard Medical Division in Covington, GA.
The purpose of this position is to assist Quality Assurance Management in maintaining a department of qualified, motivated, and respected Quality Engineers. This includes assisting all Quality Engineers with the proper tools and guidance to be successful in performing their work, as well as providing them with a work environment conducive to personal and professional success. Additionally, the Senior Quality Engineer functions as a subject-matter resource for Engineering, Operations, Sterilization and outside suppliers.
• Ability to perform engineering work of a broad nature with little or no direction from Quality Management. Generally, receives guidance on novel or controversial problems. • Extensive knowledge of medical device regulation, industry or international standard, including management responsibility. Ability to understand Division and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency. Ability to interface with regulatory bodies to present technical information. •Comprehensive knowledge of quality systems and relationship to business. •Has experience in writing process, software, and equipment protocols/validations and has fundamental knowledge of validation principles. •Understands basic applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE and Taguchi. •Ability to serve in leadership roles on projects or assignments. •Comprehensive understanding of auditing principles and ability to perform as a lead auditor. •Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understands team functions, leadership techniques and project management methodologies. •Broad knowledge of manufacturing processes. •Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience. •Understands Fundamentals of Engineering Principles. •Ability to effectively manage time. •Ability to handle multiple task assignments. •Ability to translate quality requirements into product specifications. •Ability to interpret Regulations, Corporate, Division and Department Procedures.
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.
his position works in a normal office environment. The noise level in the work environment is quiet to moderate.
Frequent travel is required. When traveling to clinical sites or hospitals, the work environment will be specific to the area under evaluation.