Quality Engineer

General Information
  • Date Job Description Completed:  28 December 2016
  • Department Name:  Quality and Regulatory Affairs
  • Reports to:  Director of Quality
  • Supervises:  None
  • Exempt/Nonexempt:  Exempt

Essential Duties and Responsibilities

  • Acceptance Activities
    • Develop and initiate standards and methods for inspection, testing, and evaluation of in process components and finished products.  Perform necessary in-house testing; inspect in-process manufacturing processes and product, release finished goods shipments to customers.
    • Initiate and coordinate laboratory testing of raw materials, assemblies, finished goods and environmental conditions.
    • Coordinate, review, and approve validation of methods, equipment, products, processes, and systems. 
    • Implement quality methods throughout the organization; drive the use of quality tools in operations and product development, assist in resolving major quality issues.
    • Plan and direct activities concerned with development, application, and maintenance of Quality standards for manufacturing processes, materials, and products. 
    • Devise sampling procedures and designs and develop forms and instructions for recording, evaluating, and reporting quality and reliability data.
    • Schedule and conduct Quality system audits of material and service suppliers. 
    • Develop and implement methods and procedures used in disposition of discrepant material, including failure investigations associated with Customer Experiences and material non-conformances detected during inspection, manufacturing, assembly, or service processes.
    • Support workers engaged in measuring and testing product and tabulating data concerning materials, product or process quality and reliability. 
    • Compile and write training material and conduct training sessions on Quality requirements and activities.
    • Coordinate and oversee sterilization validation activities and partner with suppliers to document validation activities associated with material or services provided.
Responsibility and Authority Affecting Quality
  • Initiate action to prevent the occurrence of any nonconformities relating to the product, process and Quality System.
  • Identify and record any problems relating to the product, process and quality system.
  • Conduct formal root cause analyses to identify appropriate solutions (corrective and preventive actions).
  • Initiate, recommend or provide solutions through designated channels.
  • Verify the implementation of solutions.
Position Requirements
  • Skills and abilities (required for the job)
    • Excellent communication skills
    • Excellent writing skills
    • Strong organizational skills
    • Detail oriented
    • Ability to handle multiple tasks simultaneously
    • A team player
  • Education, experience and training (required for the job)
    • Bachelor’s degree in Science or Engineering and three to five years experience in either the Medical Device or Pharmaceutical industry
    • ASQ or related CQE certification
  • Working environment
    • Work Station Area:  Office
    • Special Factors in the Work Area:  None
    • The working environment is indoors and is seasonally heated and cooled with minimal noise levels.  
    • The position requires considerable sitting, typing and the ability to move objects of less than 25 pounds.
    • The position requires the ability to communicate in person, telephonically and via email. 
Apply Today

Interested in applying for this position? Please send your cover letter and resume to humanresources@syncardia.com.