Quality Engineer

• PURPOSE OF POSITION: The Quality Engineer provides analysis and sytems development to ensure products are manufactured to meet or exceed customer requirements and expectations. The Quality Engineer works to improve quality for the product while identifying and eliminating waste.

• ROLES AND RESPONSIBILITIES
• Develops and initiates standards and methods for inspection and testing.
• Conducts root cause analysis, analyze failures, and implement corrective action for process-product related concerns and customer complaints.
• Interfaces with customers to resolve complaints, corrective actions, engineering changes and validation requirements.
• Performs and analyzes capability studies, gage, R&R, and first article reports on both new and existing products.
• Facilitates improvements to the Quality Management System via updates to procedures and work instructions stemming from audit findings and continuous improvement initiatives.
• Works with engineering to coordinate and prepare sample submission packages; updates and maintains process flow diagrams and process control plans.
• Works with operations on lean and scrap reduction initiatives.
• Works with Engineering to coordinate and prepare sample submission packages; updates and maintains process flow diagrams and process control plans.
• Works with Operations on lean and scrap reduction initiatives
• Works with Engineering and Operations to solve in-house quality concerns, reviews of non-conforming product, recommends disposition and corrective action to prevent reoccurrence.
• Creates and maintains company quality documentation, such as quality procedures, work instructions and forms.
• Prepares various quality reports
• Participates in new project launch teams.
• Compiles and prepares training material and conducts training sessions on quality control activities.
• Perform other duties as assigned.

• QUALIFICATIONS AND EDUCATION REQUIREMENTS
• Education Requirements
  • Preferred Associates or bachelor’s degree in Quality, Engineering, Statistics or technical field with a minimum of three (3) to five (5) years of Quality experience in a manufacturing environment – preferably medical manufacturing.
• Qualifications
  • Experience in Quality Assurance in an ISO or FDA or cleanroom registered manufacturing environment.
  • Sound knowledge of 21CF820 and/or ISO 13485 quality systems.
  • Must have strong working knowledge of Statistical Process Control (SPC) methods using intermediate to advance statistics.
  • Ability to work with mathematical concepts, such as probability and statistical inference and fundamentals of plane and solid geometry and trigonometry.
  • Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.
  • Excellent Communication skills – written and verbal.
  • High degree of organization and self-motivation.
  • Ability to work in a team environment.
  • Prior experience with an Enterprise Resource Planning (ERP) system.
  • Demonstrated proficiency with Microsoft Office products.
  • Well-organized and task oriented.
  • Must be able to work under pressure and meet deadlines.
• Other Key Factors
  • CQE or CQA preferred.
  • Six Sigma Green Belt certification preferred.
  • Working knowledge of G, D, & T including the ability to read and interpret engineering drawings, schematics and specifications.

• PREFERRED SKILLS
• Language Skills
  • Ability to read and comprehend correspondences and make sound decisions based upon the information.
  • Ability to write complex memorandums to communicate to customers.
• Mathematical Skills
  • Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Reasoning Ability
  • Ability to apply common sense understanding to carry out detailed written or oral instructions.
• Computer Skills
  • Advanced Microsoft Office Skills
  • Experience in Enterprise Resource Planning (ERP) systems.
• Physical Demands
  • While performing the duties of this position, the employee is regularly required to use hands to finger, handle or feel and reach with hands and arms. The employee is frequently required to stand, walk, talk, and hear.
  • The employee is regularly required to sit for long periods of time.
  • The employee must be able to walk steps between the floors in the building regularly.
  • Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
• Work Environment
  • The noise level in the work environment is usually moderate.
• Safety
  • All employees will be provided training on working safely, evacuation procedures, accident reporting and other safety topics the company feels are necessary to ensure and maintain a safe work environment from hazards to the employee.
  • An employee who does not feel safe or recognizes an unsafe practice, should report it immediately to their supervisor as a recognized responsibility of the position.

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