Quality Engineer

Here at SynCardia we have a very special mission: to give end-stage heart failure patients the priceless gift of more time. More time with their families and friends, more time outside the hospital enjoying life and more time to receive a heart transplant.

As a Quality Engineer you will support the maintenance of the Quality System in accordance with 21 CFR 820, 803, 806 and ISO 13485. By implementing quality methods throughout the organization, driving the use of quality tools in operations and product development, and assist in resolving major quality issues. Our Quality Engineers also support activities concerned with development, application, and maintenance of Quality standards for manufacturing processes, materials, and products.

Position Specific Duties and Responsibilities

• Ensure the Quality System is compliant with 21 CFR 820, 803, 806 and ISO 13485.
• Develop and initiate methods and procedures 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.
• Implement quality methods throughout the organization; drive the use of quality tools in operations and product development, assist in resolving major quality issues.
• Prepare, collect, and evaluate appropriate quality and productivity metrics.
• 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 for disposition of discrepant material.
• Direct 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.
• Review and approve protocols and reports as needed ensuring proper compliance to regulations.
• Support innovation in responsibility areas through implementation of continuous improvement opportunities to achieve operational excellence.
• Establish appropriate metrics and analyze key performance indicators to support monitoring of quality system adequacy and effectiveness.

Position Requirements

• Excellent communication skills
• Excellent writing skills
• Strong organizational skills
• Detail oriented
• Critical/Logical Thinking
• Ability to effectively follow systems
• Ability to handle multiple tasks simultaneously
• Ability to prioritize tasks in a fast-paced environment
• Must possess an proficient ability to read, write, comprehend and speak English.

Education, experience, and training

• ASQ Certified Quality Engineer and/or Six Sigma black belt preferred
• Bachelor’s Degree in Engineering or Life Sciences required. (Note: Associate Degree or Technical education in Engineering or Life Sciences and 5+ years of experience in a regulated industry accepted (examples include: Medical Devices, Pharmaceuticals, Aerospace).
• 3-5 years of experience in a quality related field
• 1-3 years working at a class II or III medical device company
• Experience with electronic/hard copy document management systems
• Understanding of GMP/GDP/GLP guidelines