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Synchron · 8 hours ago

Senior Quality Engineer (San Diego, CA)

San Diego, California, United States

Full-time

Onsite

Senior Level

$140K/yr - $160K/yr

5+ years exp

Synchron is a neurotechnology company with a mission to deliver the first commercially scalable brain-computer interface for millions of people with paralysis. They are seeking an experienced Senior Quality Engineer to lead efforts in Quality Management System compliance and provide quality engineering expertise across all 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

ISO 13485Quality Management SystemMedical device experienceISO 14791FMEADesign controlsValidation expertiseAnalytical skillsContinuous improvementInterpersonal skillsSelf-motivatedTeam collaboration

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

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