Overview: |
The Quality Engineer Manager is located in Covington, GA at Bard Medical Division
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Summary of Position with General Responsibilities: |
To maintain a department of well educated, trained, motivated and respected quality engineers to support new product development, product line extensions, and acquisitions. This includes providing them 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 development for success.
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Essential Job Functions: |
- Represent the Corporation, Division and Quality Department in a professional manner.
- Manage an engineering staff to ensure proper implementation of the Quality Engineering duties and responsibilities.
- Prepare and maintain department budget.
- Prepare, maintain, and report allocations of Cost of Quality spending to Division COQ system.
- Hire, train, develop, review, and manage exempt and non-exempt employees.
- Provide Quality Engineering support to maintain the Division Product Stability Program.
- Provide Quality Engineering support to assist in resolving quality issues that surface in the field.
- Prepare and implement divisional policies relating to quality, project management, product/process development, design control regulations, etc.
- Participate on Project Team as Quality Representative. Ensure that principals of Design Control are applied to Product and Process Changes and New Product Development.
- Provide support for Project Teams or Quality Department.
- Create, review and approve Quality System Documents.
- Create, review and approve Product Documents for products purchased, manufactured and/or distributed by BARD.
- Create, review and approve Protocols, Process and Product Validations, Stability Protocols.
- Create, Review and approve documents required for Design History File.
- Create and Review Risk Assessments such as FMEA, FMECA or FTA.
- Analyze process and product non-conformances and implement comprehensive corrective and preventive action plans.
- Perform Internal or Supplier Quality System Audits.
- Ensure compliance to Corporate, Division and Department procedures.
- Participate and have 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.
- Technical support for complaint review and investigation.
- Tracking and trending of Quality Indicators. Develop Quality indicators to enhance quality of products and business performance.
- Interface with manufacturing facilities or other Division Facilities.
- Serve as Independent QA Reviewer and Chairperson for Design Reviews.
- Participate in worldwide business travel as required by the above duties and responsibilities.
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Basic Qualifications: |
• Strong Verbal and written communication skills and presentation skills.
• Technical writing skills.
• Management skills.
• Budgeting skills.
• Computer skills
• Knowledge and understanding of Document Control practices.
• 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 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.
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Additional Desirable Qualifications Skills and Knowledge: |
Complexity: Highly variable operations performed daily, from complex regulatory and engineering decisions to routine administrative functions. This position involves reviewing and making decisions involving Personnel, Statistics, Engineering, document Control, Policy, Procedure, Specifications, Quality Acceptance, Product Development, and Regulatory Compliance issues.
Judgement: The position involves making decision involving all areas mentioned above. In some instances, there are written policies or procedures that have to be interpreted. In some instances, only judgment based on past experience can be used.
- Basic applied Statistics, statistical sampling plans, statistical process control, DOE, Taguchi Methodology.
- Able to take theoretical mathematics and apply to business problems.
English required.
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Education and/or Experience: |
- Four (4) year Science, Engineering, Technology, or Business Degree.
- Eight (8)+ years experience in a decision-making quality engineering position or equivalent quality related experience with at least 2 years in FDA Regulated Industry.
- American Society of Quality (ASQ) Certified Quality Engineer or Certified Quality Manager
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Physical Demands: |
The physical demands as required to perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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Work Environment: |
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Office environment
- Manufacturing environments
- May include visits to clinical sites or hospitals.
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