Director, Quality

Quality & Regulatory                ·                Brooklyn, New York, United States               ·             Full time

Director, Quality

Brooklyn, New York, United States

About Synchron 

Synchron is a clinical-stage endovascular brain computer interface (BCI) company. Since 2012, the company has been developing a BCI platform that avoids the need for open brain surgery by using a minimally-invasive procedure. The Synchron Switch™ BCI received FDA Breakthrough Device Designation in 2020, and is currently in human clinical trials in the US and Australia.

The company recently announced an oversubscribed $75 million Series C financing round led by ARCH Venture Partners, with participation from Gates Frontier, Bezos Expeditions and other top-tier investors. The funds will accelerate product development, facilitate commencement of a pivotal clinical trial, and advance Synchron towards a first-in-class BCI market approval for the treatment of paralysis.

The Synchron Switch™ brain computer interface is implanted in the blood vessel on the surface of the motor cortex of the brain via the jugular vein, through a minimally-invasive endovascular procedure. Once implanted, it is designed to detect and wirelessly transmit motor intent out of the brain, restoring a capability for severely paralyzed patients to control personal devices with hands-free point-and-click. Synchron is a dynamic, multi-disciplinary and rapidly growing team.

Join our mission of developing a first-in-class commercial BCI for more than 100 million people worldwide with upper limb impairment. Help people with previously untreatable conditions regain connection to the world.

The Director of Quality is responsible for implementing and maintaining a lean quality management system that meets internal business objectives and regulatory requirements. The Director of Quality sets the strategy and goals for the design assurance quality engineering team and is responsible for all aspects of product quality and performance throughout a product’s lifecycle from new product development through on-market product performance. This role ensures quality assurance through application of established procedures and policies, best practices and appropriate compliance standards within the area of responsibility. Additionally, the role has cross-functional influence and responsibility, is a key thought leader and an expert resource.

Responsibilities

• Responsible for implementing and maintaining the Quality Management System.
• Management of QMS for ongoing clinical studies.
• Approval signatory for key documents including product risk assessments, DHF deliverables, trend signal reviews/reports, and high-risk investigations.
• Interact and communicate with senior leadership regarding risks, mitigation plans, and status updates on quality objectives.
• Work with cross-functional leadership to find operationally efficient approaches to align activities and complete deliverables.
• Direct the device quality activities across multiple design and development sites.
• Stay apprised of the latest developments in Quality to provide recommendations on corporate policies and procedures to optimize quality assurance and increase compliance.
• Ensure company is audit ready.
• Foster a collaborative environment which motivates a diverse team to fully use its capabilities in achieving desired business results in accordance with Synchron’s Mission, Vision and Values.

Minimum Qualifications

• 8+ years of experience with at least 4 years at a start-up company in Class III medical device quality assurance (neuro or cardio preferred) with roles showing increasing responsibility.
• A broad technical background is required, preferably a graduate level degree, or as a minimum, a bachelor’s degree in a major scientific discipline.

Skills and Knowledge

• Have working knowledge of applicable standards (e.g. IEC 60601-1, IEC 62304, EN ISO 14971, IEC 62366-1, IEC 62366-2, EN 556-1, EN ISO 11135, EN ISO 10993, ASTM D4169 etc.)
• BIMO, QSR 21 CFR Part 820 and ISO 13485 audit experience.
• Proven ability to prioritize, conduct, and manage time to meet project deadlines.
• Strong ability to interpret regulations and standards relative to new technology and product development.
• Have the insight to problem-solve proactively on quality issues.
• Understand various options for rapid commercialization of new technologies while keeping the business informed of impact to timing.

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.

Salary range: $170k-$200k

Please click here to apply.