Senior Quality Engineer-Operations-CA

Synchron; San Diego (CA); On-site; USD 130,000 - 150,000; Full time

Benefits offered by this job

Healthcare and dental insurance

401(k)

Discretionary PTO

Commuter benefits

Job summary

Synchron is seeking a Senior Quality Engineer (Operations) in San Diego to lead manufacturing quality, support design transfer, and drive continuous improvement across production. You will collaborate with Manufacturing Engineering, Supply Chain, Operations, and R&D to ensure products are manufactured safely, consistently, and in compliance with regulatory requirements.

The role requires hands-on engagement on the floor and with contract manufacturers, including development of QMS, validation

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, Electrical Engineering, or related field.
• 7+ years of quality engineering experience in FDA-regulated medical devices.
• Hands-on support for development and manufacturing with process validation.

Responsibilities

• Manufacturing Quality: serve as Quality representative, develop quality plans and process controls.
• Process Validation & Manufacturing Readiness: lead IQ/OQ/PQ activities and validation docs.
• Supplier & Contract Manufacturer Quality: oversee supplier quality and audits.
• Design Transfer & Change Management: ensure successful transfer to production and documentation.
• Quality Systems & Compliance: maintain SOPs, prepare for audits and regulatory submissions.
• Continuous Improvement: drive Lean, SPC, and risk-based decision making.

Skills

Quality engineering

Regulatory compliance

Root cause analysis

CAPA investigations

Cross-functional collaboration

Education

Bachelors in Mechanical Engineering

Bachelors in Biomedical Engineering

Bachelors in Electrical Engineering

Tools

FMEA

Change Control

MSA/Gage R&R

QMS documentation

Job description

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.

Senior Quality Engineer (Operations)

Quality

Location: San Diego, CA (On-site) Please note must be located within commuting distance of San Diego, CA.

Employment Type: Full-Time

About The Role

As Senior Quality Engineer (Operations), you will serve as the Quality lead supporting Synchron’s manufacturing operations, contract manufacturers, and supplier network to ensure products are manufactured safely, consistently, and in compliance with applicable regulatory requirements. You will partner closely with Manufacturing Engineering, Supply Chain, Operations, and R&D to establish robust manufacturing processes, support design transfer activities, and drive continuous improvement across production operations.

You will also assist in the development and implementation of Synchron’s QMS. This is a hands‑on role requiring regular engagement on the manufacturing floor, with suppliers, and across cross‑functional teams.

Key Responsibilities

Manufacturing Quality

• Serve as the Quality representative supporting manufacturing operations and production readiness.


• 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.


• Maintain supplier quality agreements and supplier performance scorecards.


• 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.SES, CERTIFICATIONS

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


• 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


• Ability 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

Compensation

The base salary range for this role is $130,000 – $150,000 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.

Benefits (for W-2, full‑time, exempt employees in the US only) ***Intern positions not eligible

• 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

Equal Employment Opportunity (EEO)

Synchron is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and provide equal employment opportunities without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable law.

If you need a reasonable accommodation during the application or interview process, please let us know.

Join Us

At Synchron, you will be part of a transformative mission, and you will work alongside driven people who believe in the power of collaboration and innovation to make a lasting impact. If you are excited to stretch your skills and contribute to something meaningful, build the future with us.