Senior Quality Systems Specialist

About the Job

We are seeking an experienced Senior Quality Systems Specialist to join Synchron’s Quality team. This is an amazing opportunity to shape the future of Synchron’s Quality Management System (QMS) and contribute to the Culture of Quality at the company. We are looking for candidates with experience working within FDA regulated industries (preferably medical devices) and who have experience performing document control within an eQMS (preferably Arena).

The ideal candidate will be detail-oriented, process-driven, and comfortable working cross-functionally in a growing company with evolving needs.

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!

New York, NY (on-site)

• Document Control - Own the Document Control process including processing change requests and change orders for documents in Synchron’s eQMS (Arena), identifying improvement opportunities for the process, and educating company personnel on Document Control best practices
• eQMS Administration - Administer and manage the Arena eQMS including configuration, account allocation, and license management
• Training Management - Own the Personnel Training process in the QMS including determining initial Quality Training needs, assigning employee Quality Training Plans, monitoring training completion, and maintaining training records and certifications
• QMS Process Development - Drive the maintenance and development of existing and new Synchron SOPs to meet Synchron business needs, current regulations, and standards by employing industry experience and knowledge of QMSR, GLP, GMP and FDA compliance standards
• Quality Process Execution - 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 with internal procedures
• Management Reviews - Support Quality Management Reviews, including taking meeting minutes, preparing data and information for the review, and publishing the review in the QMS
• Audits - Assist with audit preparation and execution, resolution of audit findings, interactions with auditors 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

• 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 administering 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

• 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…