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.
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