What are the responsibilities and job description for the Senior Quality Systems Engineer position at Synchron Inc.?
About Synchron
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!
Job Location
Brooklyn/New York City (on-site)
Job Responsibilities
QMS Administration and Process Development
- 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
Document Control
- 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
Training Management
- Own the Personnel Training process in the QMS including determining role-based training plans, monitoring training completion, and maintaining training records
Quality Process Execution
- 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
Management Reviews and Quality Metrics
- Support Quality Management Reviews by preparing data and information for the review
- Analyze QMS metrics to monitor process effectiveness and identify improvement opportunities
Audits
- 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
Culture of Quality
- 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
Required Qualifications
- 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-Have Qualifications
- 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
Compensation
The base salary range for this role is [$120,000 – $160,000], depending on experience, skills, and qualifications. In addition to base pay, this role may be eligible for discretionary bonuses and/or equity grants subject to board approval and company policy.
Visa Sponsorship
We are unable to offer visa sponsorship for this position currently.
Benefits (for W-2, full-time, exempt employees in the US only) ***Intern positions not eligible
- 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
Equal Employment Opportunity (EEO)
Synchron is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and provide equal employment opportunities without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable law.
If you need a reasonable accommodation during the application or interview process, please let us know.
Join Us
At Synchron, you will be part of a transformative mission and you will work alongside driven people who believe in the power of collaboration and innovation to make a lasting impact. If you are excited to stretch your skills and contribute to something meaningful, apply and now and build the future with us.
Salary : $120,000 - $160,000