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.