Senior Quality System/Document Control Specialist

Quality & Regulatory      ·       Brooklyn, NY       ·      Full time

About Synchron

Synchron is developing a platform of brain interface technology that transmits data in and out of the brain via devices implanted inside cerebral blood vessels using minimally invasive endovascular procedures (Neuro-Intervention).

As a leader in brain-to-machine communication, Synchron is poised to create a significant impact in its industry and to meaningfully impact many peoples’ lives. Whilst the company’s technology is maturing fast (4 clinical trial participants have already benefited from the first-generation device), there is an opportunity to help shape the company’s direction and to work in a dynamic, multi-disciplinary and growing team.

We are a lean, fast-paced, passionate team pushing the boundaries of what is possible in the neurotech space to dramatically improve the quality of life of millions of people globally, and we want you to join us.

Senior Quality System/Document Control Specialist

As Senior Quality System Specialist, you will have responsibility for the development and maintenance of quality systems, processes and procedures, including administration and configuration of Synchron’s eQMS. Your work will be instrumental to meeting customer and regulatory requirements. It will also be part of your role to instill a culture of quality, setting the expectation within the company and for our suppliers that we do things right for our patients.

We are a lean, fast-paced, passionate team pushing the boundaries of what is possible in the neurotech space to dramatically improve quality of life of millions of people globally. We want you to join us.

Responsibilities  

• Process and execute documents undergoing Document Change Control (assignment, tracking, closure) to ensure adherence to regulatory requirements and current site practices
• Administer the Arena electronic Quality Management System
• Schedule and coordinate quarterly Quality Management Reviews, including taking meeting minutes, following up on action items and publishing review in document control
• Responsible for the maintenance of QSR, GLP, GMP and FDA compliance standards and keeps up to date on current regulations and industry standards
• Assist with audit and inspection preparation, resolution of audit and inspection findings and should be comfortable liaising with auditing groups and inspectors through all stages of the audits
• Participate in cross-functional project teams as a department representative
• Provide support with regulatory audits and inspections as required
• Foster a culture of collaboration, partnership, teamwork, and a drive for change and continuous improvement
• Facilitate uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of the company’s mission globally
• Use creative problem solving to partner with cross-functional team members to respond to, and resolve, issues
• Perform other duties and responsibilities as assigned

Minimum Qualifications  

• Bachelor’s degree with 3+ years of experience in a FDA regulated environment e.g. pharmaceutical, biotech, or medical device
• Experience in using an electronic quality/document management system (preferably Arena)

Skills and Knowledge  

• Knowledge of Document Control standards, practices, and principles
• Understanding of Quality Systems and applicable GMP regulations and standards
• Demonstrated ability to perform detail-oriented work with a high degree of accuracy
• Effective written and oral communication skills
• Effective time management and interpersonal skills
• Possesses initiative and is proactive
• Knowledge of the Microsoft suite (i.e. Word, Excel, Teams, PowerPoint, etc.) and Adobe
• Excellent organizational and planning skills
• Must work effectively within teams with rapidly changing priorities

Preferred Qualifications  

• Experience transitioning from manual to electronic QMS and/or eQMS implementation
• Experience with class III medical devices in an area such as neuromodulation, vascular devices or cardiac rhythm management
• Experience participating in quality inspections

At Synchron, we value our culture and the way we work together to achieve our goals. You will be among a group of hard-working, fun and caring people who support each other and are passionate about bringing life-changing technologies to people.

Synchron provides equal employment opportunities to all employees and applicants for employment, and prohibits discrimination and harassment of any type without regard to race, ethnicity, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. 

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