Job Description Summary
BD Urology and Critical Care is currently hiring a Principal Quality Engineer – Risk Management. This position is 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.
Summary of Position with General Responsibilities
The purpose of this position is to assist Quality Systems 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 Principal Quality Engineer – Risk Management functions as a subject-matter resource for Risk Management.
Essential Job Functions
Represents the Corporation, Division and Quality Department in a professional manner.
Program leader ensuring new methods and processes and review technical instructions to ensure compliance with Department and Division procedures and regulatory standards, with an emphasis in Risk Management.
Provides Quality Assurance leadership for Quality Department or Project Teams.
Composes risk management documents, including design Failure Modes and Effects Analysis (FMEA) that comply with Risk Management standards.
Oversees Risk Management documents developed to support development projects. Ensures that principals of Design Control & Risk Management are applied to Product and Process Changes and all design phases for New Product Development and/or product enhancements.
Oversees with other functions on the development, evaluation, reviewing, and approving Risk Management Files (FMEA, FMECA, FTA, Risk Benefit Analysis).
Provides leadership and technical expertise for Risk Management programs.
Mentors entry point staff, acting as the subject matter resource for risk management.
Performs Complaint review and investigation.
Supports and participates in regulatory agency audits related to risk management.
Ability to work independently and within a team environment.
Ability to write reports, business correspondence, and procedural manuals.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and general public.
Creates, reviews and approves Quality System Documents (CAPA, Audits), as required.
Creates, reviews and approves Product Documents, such as Protocols, Process and Product Validations, Stability Protocols, Software Validation documents, as required.
Analyzes process and product non-conformances and implement comprehensive corrective and preventive action plans, as required.
Interfaces with manufacturing facility or other Division Facilities, as required.
Serves as Independent QA Reviewer for Design Reviews and participate in Phase Reviews, 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, desired.
Comprehensive knowledge of quality systems and relationship to business.
Extensive knowledge of medical device regulation, industry or international standard, including risk management. Ability to perform engineering work of a broad nature with little or no direction.
Interpretation of regulations (GMP, ISO 13485, ISO 14971, EU MDR) into standards and procedures.
Ability to understand Division and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency.
Participate in development of risk management documents.
Review activities related to Design Verification and Design Transfer of Medical Devices.
Ability to interface with regulatory bodies to present technical information.
Ensure proper justification of statistical analysis and hypothesis testing.
Strong expertise in engineering concepts and statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE and Taguchi. Perform Data/Statistical analysis, as needed.
Well-versed in statistics, data presentation, and analysis application to business problems.
Ability to serve in leadership roles on projects or assignments.
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.
Strong interpersonal skills required in the areas of verbal and written communications, customer focus, professionalism, leadership, telephone courtesy, influencing, and team building skills.
Education and/or Experience
B.S. in Engineering, Engineering Technology, Science (REQUIRED)
Minimum 5 years of experience with FDA regulated industry including a minimum three years on supporting product development programs.
Minimum of two years of experience with personnel management
American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred.
Primary Work Location
USA GA - Covington BMD