Senior Quality Engineer (San Diego, CA)

About Synchron 

Synchron is a neurotechnology company with a mission to deliver the first commercially scalable brain-computer interface (BCI) for millions of people with paralysis to reconnect with the world. Our minimally invasive BCI system is designed to enable users to control digital devices directly through thought, restoring access and control over the digital world. Our team is working at the intersection of healthcare and technology to translate breakthrough research into real-world care.

Join us in shaping a more connected and accessible future. 

Location: San Diego, CA, United States (on-site)

About the Job

We are seeking an experienced Senior Quality Engineer who will play a pivotal role in Quality Management System (QMS) towards ISO 13485 compliance and provide quality engineering expertise. This is an incredible opportunity for someone who is passionate about being a leader that can work with significant autonomy and independent judgement to achieve our Quality goals and lead continuous improvement projects with cross-functional teams. We are looking for candidates with a solid background in medical devices. Experience with developing strong working relationships with both internal and external customers to influence and enable an effective Quality Culture is a must. This role will report to director of quality assurance and will be a San Diego based role.

If you possess the following and want to make a meaningful impact, we invite you to explore this role.

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.)

Required Qualifications

• 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 EU MDR, IEC 62304, 21CFR820, 21CFR 211 is strongly preferred
• 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
• 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

Compensation 

The base salary range for this role is USD 140,000 – USD 160,000 depending on experience, skills, and qualifications. In addition to base pay, 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.

Benefits (for full-time, exempt employees in the US only)

• Subsidized medical and dental insurance coverage for you and your dependent(s)  
• Life insurance, short-term disability, long-term disability