Quality Engineer, Medical Devices & QMS Specialist

Galvanize; Redwood City (CA); In loco; USD 115.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health benefits

Life insurance

401(k) & PTO

Descrizione del lavoro

Galvanize Therapeutics, based in Redwood City, CA, seeks a Quality Engineer to support the Quality Management System, CAPA reviews, supplier audits, and compliance with ISO 13485, 21 CFR Part 820, and ISO 14971. The role involves new product development support, risk management, and QMS enhancements, with travel about 25% to supplier sites.

Applicants should have a B.S. in Mechanical Engineering or related field and 2–5 years in medical device quality, plus strong documentation and

Competenze

• 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%) to support supplier audits.
• Proficiency in Mandarin preferred (speaking, reading, and writing).

Mansioni

• 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, Fault Tree Analysis for systems, and other workflows to ISO 14971.
• Drive risk mitigation, including verification of risk mitigations, through design and product requirement definitions.
• Support receiving inspection, inventory, purchasing, and other activities if requested to do so.
• Support qualification of suppliers in Galvanize’s QMS, inclusive of performing supplier evaluations and working with suppliers to obtain necessary documentation for their qualification in the QMS.
• Support Software Verification/Validation activities related to R&D, sustaining engineering, and QMS.

Conoscenze

Medical device QMS experience

Manufacturing environment

Technical writing

Independent work

Medical devices knowledge

Quality standards ISO 13485/820/14971

Travel to supplier audits

Mandarin preferred

Formazione

B.S. in Mechanical Engineering

Descrizione del lavoro

Galvanize Therapeutics, based in Redwood City, CA, seeks a Quality Engineer to support the Quality Management System, CAPA reviews, supplier audits, and compliance with ISO 13485, 21 CFR Part 820, and ISO 14971. The role involves new product development support, risk management, and QMS enhancements, with travel about 25% to supplier sites.

Applicants should have a B.S. in Mechanical Engineering or related field and 2–5 years in medical device quality, plus strong documentation and