Senior Quality Engineer

Job Overview

Here at Syn Cardia we have a very special mission: to give end-stage heart failure patients the priceless gift of more time—more time with their families, outside the hospital enjoying life, and in the process, a chance to receive a heart transplant.

As a Senior Quality Engineer you will support the maintenance of the Quality System in accordance with 21 CFR 820, 803, 806 and ISO 13485, including preparation and maintenance of compliance to ISO 14971. You will implement quality methods throughout the organization, drive the use of quality tools in operations and product development, and assist in resolving major quality issues.

• Ensure the Quality System is compliant with 21 CFR 520, 803, 806 and ISO 13485.
• Promote awareness of the Quality System and provide training to individuals across the organization on quality management philosophies, tools, techniques and best practices.
• Provide training and direction to junior team members within the Quality department.
• Implement cost of quality concepts, including quality cost categories, data collection, and reporting for manufacturing.
• Conduct inspections of components and subassemblies, documenting compliance to approved specifications and procedures.
• Initiate and coordinate laboratory testing of raw materials, assemblies, finished goods and environmental conditions.
• Devise sampling procedures and develop forms and instructions for recording, evaluating and reporting quality and reliability data.
• Schedule and conduct Quality System audits of materials and service suppliers.
• Coordinate and oversee sterilization validation activities.
• Ensure systematic planning and control of product and process quality in manufacturing.

• Material control.
• Acceptance activities.
• Measurement systems.
• Implement a validation program for new or changed materials, equipment, processes, and components.

• Implement and support quality improvement models.
• Corrective and preventive action.
• Overcome barriers to quality improvement.
• Quality System support.

• CAPA handling and investigation.
• Guidance for completing failure investigations.
• Participation in external audits—develop responses to queries.
• Risk Management.

• Initiate actions to prevent nonconformities.
• Identify and record potential problems.
• Recommend solutions through designated channels.
• Record and report customer feedback.
• Verify implementation of solutions.
• Report progress and results of projects to the Quality Manager.

• Excellent communication, writing, organizational, and detail-oriented skills.
• Strong problem‑solving and critical thinking.
• Ability to handle multiple tasks simultaneously and work independently as part of a cross‑functional team.
• ASQ Certified Quality Engineer and Six Sigma black belt preferred.
• Bachelor’s degree in a related field or equivalent combination of education and experience.
• 6–10 years of experience in a regulated industry (medical device preferred). At least 5 years in a Class II or III medical device company.
• Advanced degree in Engineering or Life Sciences acceptable in lieu of professional experience.
• Thorough understanding of quality philosophies, principles, systems, methods, tools, and standards.
• Experience with audit planning, execution, reporting and follow‑up.
• Ability to develop and implement quality programs, including tracking, analysis, reporting and problem solving.
• Knowledge of statistical analysis, reliability, maintainability and risk management.
• Proficiency with quality improvement tools, preventive and corrective actions, and overcoming barriers to improvement.
• Ability to analyze manufacturing data using quantitative and statistical methods to facilitate process analysis and improvement.