Quality Assurance Manager

Description

At Syn Cardia, we are on a mission to transform lives with our life saving total artificial heart technology. We are looking for a driven, detail oriented Quality Assurance Manager. In this role, you will lead the systems and processes that ensure our products meet the highest standards of safety, reliability, and regulatory compliance. You will oversee quality system maintenance, internal and external audits, supplier quality, nonconformance and CAPA management, and cross functional support for production and engineering teams.

This position also plays a key role in supporting FDA, ISO, and international regulatory requirements. If you are ready to make an impact and thrive in a fast paced, mission driven environment, we would love to hear from you.

• Manage QMS processes to ensure full compliance with procedural and regulatory requirements.
• Ensure the Quality System meets 21 CFR 820, 803, 806 and ISO 13485 requirements.
• Maintain and improve quality methods, tools, and processes across manufacturing and engineering.
• Initiate action to prevent nonconformities related to products, processes, and the Quality System.
• Identify, document, and communicate potential quality issues and customer feedback.
• Verify the implementation and e_ectiveness of corrective and preventive actions.

• Oversee inspection of incoming materials, purchased components, subassemblies, and finished goods.
• Conduct or supervise inspections of components and subassemblies; document compliance to approved specifications.
• Manage inspection of device history records to ensure compliance before product release.
• Ensure finished devices consistently meet quality standards based on documented requirements.
• Initiate and coordinate laboratory testing of raw materials, assemblies, finished goods, and environmental conditions.
• Develop and implement methods and procedures for disposition of discrepant materials.
• Document and communicate all acceptance activities per approved procedures and forms.

• Review, write, and revise quality control specifications and acceptance criteria; prepare supporting documentation.
• Support document management activities across Quality Engineering and Document Services.
• Manage quality documentation to ensure accuracy, traceability, and regulatory readiness.

• Prepare and submit documents, including IDEs, PMAs, and Design Dossiers, to domestic and international regulatory authorities.
• Interface with regulatory agencies to obtain marketing approvals, including FDA and CE Mark.
• Support regulatory filings and submissions in collaboration with cross functional teams.

• Manage day to day operations of Quality Engineering, Document Services, and Customer Experience personnel.
• Provide training and direction to sta_ on inspection methods, documentation reviews, and quality processes.
• Partner closely with Engineering and Manufacturing to resolve quality issues and improve processes.
• Perform basic statistical analysis and communicate results to Engineering and leadership.

• Excellent verbal communication skills with the ability to collaborate across teams.
• Strong writing skills with the ability to prepare clear, concise documentation. Highly organized with strong attention to detail.
• Ability to manage multiple tasks and priorities in a fast paced environment.
• Proven team player with a proactive, solution oriented mindset.
• Ability to read and interpret technical specifications, engineering drawings, and blueprints.
• Ability to maintain accurate, audit ready records and documentation.
• Proficiency using common inspection tools, including calibrated micrometers, depth gauges, rulers, and microscopes.
• Basic statistical knowledge, including calculation of averages, standard deviations, and interpretation of results.

• Bachelor’s degree required; master’s degree preferred.
• 5–10 years of experience in Quality Assurance, Quality Engineering, or related function.
• Significant experience in a regulated environment (medical devices, pharma, biotech, aerospace).
• Minimum 2–3 years working specifically with Class III medical devices.
• Experience managing or maintaining a Quality Management System (QMS).
• Experience leading audits (FDA, ISO 13485, notified bodies).
• Experience with nonconformance, CAPA, complaint handling, and risk management processes.
• Experience supporting production, design, and supplier quality preferred.
• Experience with electronic and hard-copy quality management systems.

The role is office-based, with hybrid or remote options available depending on business needs. The working environment involves moderate noise levels and may occasionally require lifting items weighing up to 30 pounds.