Summary of Position with General Responsibilities:
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.
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.
• 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.
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.
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.
C. R. Bard - 22 months ago
C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...