Senior Quality Systems Engineer

Synchron Inc. • New York, NY

18h • Onsite

About The Position

Synchron’s vision is to build non-surgical brain–computer interfaces at global scale that protect the fundamental human rights of freedom of expression and autonomy. Our first mission is to develop motor decoders that restore the ability of 15 million people with paralysis to interact with the digital world. Our second mission is to develop whole-brain cognitive decoders that enable hundreds of millions of people with cognitive decline to preserve and expand their agency as cognition changes over time. In pursuing these goals, we aim not only to help humans flourish, but also to drive fundamental discoveries in human intelligence. Our team operates at the intersection of healthcare and technology, translating breakthrough research into real-world, safety-critical systems.

About the Role

We are seeking a Senior Quality Systems Engineer to play a key role in the maintenance and optimization of Synchron’s Quality Management System (QMS). This individual will apply systems thinking and regulatory knowledge to implement and continuously improve quality processes that support Synchron’s product development and clinical operations. This role will work cross-functionally to ensure quality processes are compliant and effective. We are looking for people with experience working within FDA regulated industries (preferably medical devices) who are comfortable operating in a fast-paced environment.

Synchron is a patient first company full of mission-driven people with a passion for problem-solving and doing right by our patients. If this sounds like you, then we invite you to apply!

Requirements

• Bachelor’s degree in engineering, life sciences, or a related field
• 5+ years of experience working within a Quality Management System in an FDA regulated industry e.g. medical device, pharmaceutical, or biotech
• Knowledge and understanding of medical device Quality Management Systems and applicable regulations and standards including 21 CFR 820 and ISO 13485:2016
• Experience using an electronic Quality Management System (preferably Arena)
• Demonstrated ability to perform detail-oriented work with a high degree of accuracy
• Excellent time management, organizational, and planning skills
• Effective written and oral communication skills
• Must work effectively within teams with rapidly changing priorities
• Proficiency with Microsoft Office tools (i.e. Word, Excel, Teams, PowerPoint, etc.)

Nice To Haves

• Experience with class III medical devices in an area such as neuromodulation, vascular devices or cardiac rhythm management
• Experience participating in quality inspections and performing supplier quality audits
• Experience supporting investigational devices undergoing clinical trials
• ISO 13485:2016 Lead Auditor Certification

Responsibilities

• Serve as the primary administrator for Synchron’s Arena eQMS including system configuration and account management
• Drive the maintenance and development of existing and new SOPs/processes to meet business needs in alignment with 21 CFR 820, ISO 13485, and applicable regulatory requirements
• Apply risk-based thinking to identify opportunities for process improvement, automation, and simplification of Quality processes
• Own the Document Control function by processing change requests/orders and driving continuous improvement to the process
• Train and support employees on best practices for Document Control
• Own the Personnel Training process in the QMS including determining role-based training plans, monitoring training completion, and maintaining training records
• Own the execution of processes associated with clinical product handling including product receiving, inventory management, distribution, and returns
• Support processes including Supplier Management, CAPA, Product Feedback, Nonconformances, and Non-Product Software Validation by guiding cross-functional teams to develop records in accordance with internal procedures
• Support Quality Management Reviews by preparing data and information for the review
• Analyze QMS metrics to monitor process effectiveness and identify improvement opportunities
• Support internal and external audits including preparation, execution, and resolution of audit findings
• Interface with auditing groups and inspectors through all stages of audits, and perform or oversee contractors for audits of critical suppliers
• Use risk-based thinking and a creative problem-solving mindset to improve quality tools and processes
• Foster a Culture of Quality through collaboration, teamwork, and a drive for change and continuous improvement
• Perform other duties and responsibilities as assigned

Benefits

• Subsidized medical and dental insurance coverage for you and your dependent(s) 
• Life insurance, short-term disability, long-term disability 
• 401k 
• Discretionary unlimited PTO 
• Flexible Spending Account for you and your dependent(s), with eligible plan elections
• Commuter benefits for NY employees

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level