Quality Manager

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

The Manager of Quality is responsible for implementing and maintaining a lean quality management system that meets internal business objectives and regulatory requirements. The Manager 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.

*This role must be onsite 5 days per week

Key Responsibilities

• Responsible for implementing and maintaining the Quality Management System.
• Management of QMS for ongoing clinical studies, design and development activities, and manufacturing.
• Approval signatory for key documents including product risk assessments, DHF deliverables, trend signal reviews/reports, and high-risk investigations.
• Responsible for Management Reviews and interacting and communicating with senior leadership regarding risks, mitigation plans, and status updates on quality objectives.
• Works with cross-functional leadership to find operationally efficient approaches to align activities and complete deliverables.
• Directs the device quality activities related to design controls, usability, risk management and software quality across multiple design and development sites.
• Stays apprised of the latest developments in Quality to provide recommendations on corporate policies and procedures to optimize quality assurance and increase compliance.
• Ensures company is audit ready.
• Fosters 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.

Required Qualifications

• 7+ years of experience in Class III medical device regulatory affairs (neuro or cardio preferred) with roles showing increasing responsibility.
• Bachelor’s degree in a major scientific discipline with a broad technical background or equivalent experience.

Preferred Qualifications

• Start-up company experience.
• 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, QMSR 21 CFR Part 820 and ISO 13485 audit experience including ability to navigate audit findings. Lead auditor certification strongly desired.
• 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.

Compensation

The base salary range for this role is $140,000 – $165,000 depending on experience, skills, and qualifications.

In addition to base salary, 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 at this time.