SynCardia Systems, LLC · 6 days ago
Quality Assurance Manager
Tucson, AZ
Full-time
Hybrid
Senior Level
5+ years expSynCardia Systems, LLC is focused on transforming lives with their life-saving total artificial heart technology. They are seeking a driven Quality Assurance Manager to lead systems and processes ensuring product safety, reliability, and regulatory compliance while overseeing quality system maintenance and audits.
Health CareManufacturingMedicalWellness
Responsibilities
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 effectiveness 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 staff 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
Qualification
Required
Bachelor's degree required
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
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
Preferred
Master's degree preferred
Experience supporting production, design, and supplier quality preferred
Experience with electronic and hard-copy quality management systems
Company
SynCardia Systems, LLC
SynCardia Systems, LLC, a Picard Medical Company, is headquartered in Tucson, AZ.
51-200 employees
H1B Sponsorship
SynCardia Systems, LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2023 (2)
2021 (2)
Funding
Current Stage
Growth StageTotal Funding
$39.42MKey Investors
SWK Holdings
2021-09-28Acquired
2014-09-15Series Unknown· $6.42M
2013-12-23Series Unknown· $14M
Leadership Team
Don Webber
Chief Executive Officer
Patrick NJ Schnegelsberg
Chief Executive Officer
Recent News
2025-12-30
Company data provided by crunchbase