Synchron · 2 days ago
Senior Quality Engineering Manager (San Diego, CA)
San Diego, CA
Full-time
Onsite
Senior Level
$140K/yr - $160K/yr
5+ years expSynchron is a neurotechnology company focused on delivering brain-computer interfaces for individuals with paralysis. They are seeking a Senior Quality Engineering Manager to lead the Quality Management System towards ISO 13485 compliance and to provide quality engineering expertise throughout product lifecycles.
Information TechnologyManufacturingMedicalMedical Device
No H1B
Responsibilities
Spearhead development and continuous improvement of QMS processes, including but not limited to calibration and preventive maintenance program, design controls, process / design / software validation, management review etc
Interpret regulations and requirements to lead efforts related to Risk Management (FMEA), Verification & Validation, Design History File (DHF), Design Master Records (DMR), Device History Records (DHR)
Support activities related to audits, NCRs, complaints, change control and new product introductions, including problem resolution, guidance on effective CA/PA, improving documentation
Provide quality engineering expertise throughout all product lifecycles, from design and development to post-market surveillance, requiring solid understanding of the company's product portfolio and close collaboration with multiple functions (R&D, Engineering, Mfg, Supply Chain, Commercial, Software etc.)
Qualification
Required
Bachelors degree in Engineering, Biology, or related science field (an equivalent combination of experience and education may be considered)
A minimum of 5 years' experience, preferably in the medical device (Class I-II) or other regulated industry
Experience with ISO13485 and ISO 14791 is required
Experience with wide range of validation including design, process, equipment, product and non-product software is strongly preferred
Ability to work in a fast-paced and technically challenging environment where adaptability and drive are critical to success
Strong interpersonal skills with the ability to collaborate closely with suppliers and with internal stakeholders of varying levels to drive Quality System improvements
Demonstrates an ability to work independently and as part of a team
Self-motivated and able to organize and prioritize multiple tasks
Strong inclination and passion for continuous improvement
Strong analytical skills, reporting, and data analysis are strongly preferred
Preferred
Experience with EU MDR, IEC 62304, 21CFR820, 21CFR 211 is strongly preferred
Experience working with electronic Quality Management System and manufacturing-related business systems, like ERP and MES, is preferred
ISO13485 Lead Auditor certification and ASQ CQE certification is a plus
Benefits
Subsidized medical and dental insurance coverage for you and your dependent(s)
Life insurance, short-term disability, long-term disability
401k
Discretionary unlimited PTO
Flexible Spending Account for you and your dependent(s), with eligible plan elections
Commuter benefits for NY employees
Company
Synchron
Synchron is a bioelectronics medicine company that develops neuromodulation solutions for previously-untreatable nervous system conditions.
51-200 employees
Funding
Current Stage
Late StageTotal Funding
$330MKey Investors
Double Point VenturesARCH Venture PartnersMax Hodak
2025-11-06Series D· $200M
2022-12-15Series C· $75M
2022-02-04Series Unknown
Leadership Team
Thomas Oxley
CEO
Andy Rasdal
Chief of Staff
Recent News
Startup Daily
2025-12-24
Company data provided by crunchbase