Synchron · 1 day ago
Senior Quality Systems Specialist
Brooklyn, NY
Full-time
Onsite
Senior Level
$120K/yr - $160K/yr
5+ years expSynchron is a company focused on patient care and quality management. They are seeking an experienced Senior Quality Systems Specialist to shape the future of their Quality Management System and contribute to a culture of quality. The role involves managing document control, eQMS administration, and training management, among other responsibilities.
Information TechnologyManufacturingMedicalMedical Device
No H1B
Responsibilities
Own the Document Control process, including processing change requests and executing change orders for documents in Synchron’s eQMS (Arena), identifying improvement opportunities for the process, and educating company personnel on Document Control best practices
Administer and manage the Arena electronic Quality Management System including configuration, account allocation, and license management
Own the Personnel Training process in the QMS, including determining initial Quality Training needs, assigning employee Quality Training Plans, monitoring training completion, maintaining training records and certifications, and determining access to the eQMS and development tools for new hires
Drive the maintenance and development of existing and new Synchron SOPs/documentation to meet Synchron business needs, current regulations, and industry standards by employing industry experience and knowledge of QMSR, GLP, GMP and FDA compliance standards
Own the execution of processes associated with handling of clinical product, including incoming inspection, inventory management, product distribution, and product returns
Support processes including Design Control, Change Management, CAPA, Product Feedback, and Nonconformances by guiding project teams to develop records in accordance withinternal procedures
Support non-product software tool assessments and validations related to the QMS
Support Quality Management Reviews, including taking meeting minutes, preparing data and information for the review, and publishing the review in the QMS
Assist with audit preparation and execution, 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 continuous improvement mindset to improve quality tools and processes
Use creative problem solving to partner with cross-functional team members to respond to and resolve issues
Foster a culture of quality through collaboration, partnership, teamwork, and a drive for change and continuous improvement
Perform other duties and responsibilities as assigned
Qualification
Required
Bachelor's degree, preferably in the sciences but we are open to different backgrounds
5+ years of experience working within a Quality Management System in an FDA regulated environment 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/Document 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
Possesses initiative and is proactive
Must work effectively within teams with rapidly changing priorities
Builds productive internal and external working relationships
Knowledge of the Microsoft suite (i.e. Word, Excel, Teams, PowerPoint, etc.) and Adobe
Preferred
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
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
Company
Synchron
Synchron is a bioelectronics medicine company that develops neuromodulation solutions for previously-untreatable nervous system conditions.
51-200 employees
Funding
Current Stage
Late StageTotal Funding
$330MKey Investors
Double Point VenturesARCH Venture PartnersMax Hodak
2025-11-06Series D· $200M
2022-12-15Series C· $75M
2022-02-04Series Unknown
Leadership Team
Thomas Oxley
CEO
Andy Rasdal
Chief of Staff
Recent News
Startup Daily
2025-12-24
Company data provided by crunchbase