Supplier Quality Engineer — Medical Devices & Compliance

echo inc.; San Francisco (CA); On-site; USD 136,000 - 170,000; Full time

Benefits offered by this job

Stock options

401(k) matching

Comprehensive benefits

Paid time off

Job summary

Echo Neurotechnologies is seeking a Supplier Quality Engineer to join a fast-paced, medical device-focused team in San Francisco. You will partner with cross-functional groups to ensure supplier quality, manage risk, and support design transfers throughout development and production.

This hands-on role requires experience in supplier management, quality systems, and regulatory compliance. You will drive AVM activities, audits, and continuous improvement while collaborating across time zones and

Qualifications

• Bachelor’s or Master’s degree in Engineering or related field.
• 3–7 years of quality engineering or medical device development experience.
• Strong knowledge of FDA, ISO 13485, IEC 62304, ISO 14971, IEC 62366-1 in regulated environments.

Responsibilities

• Support supplier selection, evaluation, and monitoring and manage the Approved Supplier List (ASL).
• Ensure quality agreements and technical expectations with suppliers are met.
• Identify supplier risks and drive cross-functional resolution to prevent disruptions.
• Maintain procedures to ensure regulatory compliance across the organization.
• Lead or support FMEAs, process validation, IQ/OQ/PQ, and equipment qualifications.
• Define manufacturing test specs and critical quality criteria with engineering and operations.
• Execute supplier audits, qualifications, SCARs, change assessments, NCRs.
• Participate in MRB meetings and report KPIs for supplier quality.
• Coordinate audits and provide documentation for internal and external audits.
• Foster continuous improvement and quality culture across the organization.

Skills

Quality engineering

Supplier management

Risk management

FMEA

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s or Master’s degree in Engineering

Job description

Echo Neurotechnologies is seeking a Supplier Quality Engineer to join a fast-paced, medical device-focused team in San Francisco. You will partner with cross-functional groups to ensure supplier quality, manage risk, and support design transfers throughout development and production.

This hands-on role requires experience in supplier management, quality systems, and regulatory compliance. You will drive AVM activities, audits, and continuous improvement while collaborating across time zones and