C. R. Bard, Inc.

Sr. Quality Engineer- CAPA

1 month ago
Industry / Category
Sr. Quality Engineer/Quality
Job ID
2017-10451
Career Level
experienced
Division
Bard Medical
Relocation
Yes
US-GA-Covington

Overview

The Sr. Quality Engineer position is located at C. R. Bard Medical Division in Covington, GA.

Summary of Position with General Responsibilities

The purpose of this position is to provide technical quality leadership in the development and transfer of products to manufacturing facilities.

Essential Job Functions

  • Represents the Corporation, Division and Quality Department in a professional manner.
  • Participates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development.
  • Provides Quality Assurance leadership for Project Teams or Quality Department.
  • Creates, reviews and approves Quality System Documents (CAPA, Audits)
  • Creates, reviews and approves Product Documents
  • Creates, reviews, and approves Protocols, Process and Product Validations, Stability Protocols, Software Validation documents
  • Mentors entry point staff
  • Provides supervision to technicians and engineers
  • Assists in the review and interviews of potential candidates.
  • Creates, reviews and approves documents required for Design History File.
  • Creates, reviews and approves Risk Assessments such as FMEA, FMECA or FTA.
  • Analyzes process and product non-conformances and implement comprehensive corrective and preventive action plans.
  • Performs Internal or Supplier Quality System Audits.
  • Ensures compliance to Department and Division procedures.
  • 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.
  • Performs Complaint review and investigation as required.
  • Tracks and trends Quality Indicators.
  • Interfaces with manufacturing facility or other Division Facilities.
  • Serves as Independent QA Reviewer and Chairperson for Design Reviews.

Basic Qualifications

  • 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.

Additional Desirable Qualifications Skills and Knowledge

Language Skills

  • Ability to read, analyze, and interpret general business periodical, professional journals, technical procedures, or governmental regulations.
  • Ability to write reports, business correspondence, and procedure manuals.
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Mathematical Skills

  • Well-versed in statistics, modeling, optimization, data presentation and analysis and application to business problems
  • Basic applied statistics, statistical sampling plans, statistical process control, DOE and Taguchi Methodology.

Reasoning Ability

  • Highly variable operations performed daily from complex regulatory and engineering decisions to routine administrative functions. Interpretation of regulations (GMP, ISO 13485, EN46001) into standards and procedures as required. The ability to explain these interpretations to Plant, Division, Corporate, and representatives of Regulatory bodies is necessary.
  • As a senior engineer, tasks and responsibility are highly complex and very difficult. Considering a few important facts must make judgement for very complex issues; written rules, precedents and policies are available for guiding decisions, but are not always easily attained. Some facts may be difficult to attain and the relationship between facts difficult to establish. There are often instances where quick judgements must be made that can have significant impact to the Company. Individual is looked upon as a decision-resource person, one of high integrity and decision-making skills.
  • A great deal of work must be initiated through a detailed knowledge and understanding of the job function, the establishment of plans to attain the end goal. There is a great deal of freedom of action, originality and imaginative drive and critical analysis since there is not strict day-to-day supervision. The success of implementation of quality plans is largely dependent upon the person's ability to recognize the most efficient, cost-effective approach to attaining the desired goal. In many instances, the person will be required to use creativity and imagination in carrying out the job function. This person will be working in a fast-paced, technically challenging environment where drive is critical to success.
  • Decisions made by this person could have significant regulatory and financial implications. Furthermore, this person's decisions could have a significant impact on healt care practitioners and the welfare of their patients.

Education and/or Experience

  • B.S. in Engineering, Engineering Technology, Science a minimum.
  • American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.)
  • Minimum 4 years of experience with FDA regulated industry including three years on product development programs.

Physical Demands

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.

Work Environment

This 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.

 

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