MedTech Quality Engineer – NPD & QMS

Galvanize Therapeutics; Redwood City (CA); On-site; USD 115,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Life insurance

Disability protection (short & long)

401(k) & flexible PTO

Job summary

Galvanize Therapeutics, a biomedical platform company, seeks a Quality Engineer in Redwood City, CA to support design output evaluation for quality requirements and maintain the Quality Management System.

Requirements include a B.S. in Mechanical Engineering and 2–5 years in a Medical Device QMS, with manufacturing experience and ISO 13485/21 CFR 820/ISO 14971 familiarity. Travel up to 25% and Mandarin proficiency are optional assets.

Qualifications

• 2-5 years of work experience within a Medical Device Quality Management System.
• Experience working in a Manufacturing Environment.
• Proficient in writing procedures, reports, and presentations.
• Ability to work independently in a diverse and dynamic environment.
• General experience with medical devices, specifically capital equipment and disposables.
• General understanding of ISO 13485, 21 CFR Part 820, and ISO 14971.
• Ability to travel (approximately 25%).
• Proficiency in Mandarin preferred (speaking, reading, and writing).

Responsibilities

• Responsible for new product development activities.
• Support the development and deployment of the quality system that meets company objectives.
• Review and update CAPAs and complaints as needed.
• Supplier documentation and completion of Verification and Validation activities including traceability to requirements in compliance with applicable quality system regulations
• Responsible for change order implementation activities.
• Review and challenge NPD engineering related activities and documentation that includes protocols and test reports.
• Facilitate the documentation of risk management using industry standard tools including FMEAs and Fault Tree Analysis for ISO 14971.
• Drive risk mitigation through design and product requirement definitions.
• Support receiving inspection, inventory, purchasing, and other activities if requested.
• Support qualification of suppliers in Galvanize's QMS, including supplier evaluations and documentation.
• Support Software Verification/Validation activities related to R&D, sustaining engineering, and QMS.

Skills

QMS experience in medical devices

Manufacturing environment

Procedures, reports writing

Independent work in dynamic setting

ISO 13485, 21 CFR 820, ISO 14971

Travel up to 25% for supplier audits

Mandarin proficiency (preferred)

Education

B.S. in Mechanical Engineering

Job description

Galvanize Therapeutics, a biomedical platform company, seeks a Quality Engineer in Redwood City, CA to support design output evaluation for quality requirements and maintain the Quality Management System.

Requirements include a B.S. in Mechanical Engineering and 2–5 years in a Medical Device QMS, with manufacturing experience and ISO 13485/21 CFR 820/ISO 14971 familiarity. Travel up to 25% and Mandarin proficiency are optional assets.