Senior Quality Engineer-Operations-CA
About the role
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.
Key Responsibilities
Mentor and lead the Quality team supporting Synchron’s manufacturing operations, contract manufacturers, and supplier network to ensure products are manufactured safely, consistently, and in compliance with applicable regulatory requirements.
Develop and maintain manufacturing quality plans, inspection methods, acceptance criteria, and process controls.
Monitor production quality metrics including yield, defects, scrap, and process capability; identify trends and drive continuous improvement.
Support manufacturing investigations related to nonconforming product, deviations, and production issues.
Lead root cause investigations using structured problem-solving methodologies and ensure timely implementation of effective CAPAs.
Support Manufacturing Engineering during implementation of new equipment, tooling, automation, and process improvements.
Up to 20% travel expected, primarily for contract manufacturer visits and supplier audits.
Process Validation & Manufacturing Readiness
Lead or support process validation activities (IQ/OQ/PQ) for manufacturing processes, equipment, software, and inspection systems.
Develop validation protocols, reports, sampling plans, and acceptance criteria.
Support manufacturing process characterization and statistical analysis.
Maintain validated state through periodic review and change assessment.
Participate in pilot builds and production readiness activities supporting commercialization.
Supplier & Contract Manufacturer Quality
Manage quality oversight of suppliers and contract manufacturers.
Conduct supplier qualification, audits, performance monitoring, and quality system assessments.
Review supplier validation documentation, inspection methods, and process controls.
Partner with Supply Chain to resolve supplier quality issues and implement corrective actions.
Design Transfer & Change Management
Partner with R&D and Manufacturing Engineering to ensure successful transfer of new products into production.
Develop Process FMEAs, Control Plans, inspection strategies, and manufacturing quality documentation.
Evaluate manufacturing impact of engineering changes through Change Control processes.
Support Design Reviews with a focus on manufacturability, inspection, process capability, and production scalability.
Quality Systems & Compliance
Author and maintain manufacturing quality documentation including SOPs, Work Instructions, Inspection Procedures, DHRs, Device Master Records (DMRs), and validation documentation.
Support internal audits, supplier audits, FDA inspections, and Notified Body audits.
Ensure manufacturing activities remain compliant with FDA Quality System Regulation, ISO 13485, and applicable international standards.
Support implementation and continuous improvement of Synchron’s Quality Management System.
Continuous Improvement
Drive Lean Manufacturing and Operational Excellence initiatives.
Utilize SPC, capability studies, MSA, Gage R&R, and statistical tools to improve manufacturing performance.
Develop quality metrics and dashboards to support management review.
Champion risk-based decision making throughout manufacturing operations.
Required Qualifications
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related technical/science field.
7+ years of quality engineering experience in an FDA-regulated medical device environment, with hands-on experience supporting development and manufacturing of mechanical and/or electrical devices, including process validation and control plan development.
Preferred Qualifications
ISO 13485:2016 Lead Auditor Certification (or willingness to obtain).
CQE or CQA preferred.
Ability to read engineering drawings, GD&T, and electrical schematics; hands-on experience with electromechanical assembly and inspection.
Leverage lean manufacturing tools (5S, Kaizen, Statistical Process Control, poka-yoke) and applied statistics (sampling plans, MSA/Gage R&R).
Working knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, and applicable product standards (IEC 60601-1, ISO 14708, ISO 10993, IEC 62366).
Supplier quality management experience: auditing, corrective action, and quality agreements.
Strong communicator – able to author clear technical documents and collaborate across R&D, manufacturing, regulatory, and operations.
Able to work effectively within fast-paced, cross-functional teams with shifting priorities.
8+ years of medical device quality engineering experience, with 3+ years in a manufacturing environment.
Class III implantable device experience – neuromodulation, vascular, or cardiac rhythm management preferred.
Experience supporting FDA or Notified Body inspections and/or regulatory submissions.