Senior Quality Systems Engineer – Medical Devices

Lancesoft; Austin (TX); On-site; USD 90,000 - 130,000; Part time

Job summary

Lancesoft seeks a Quality Systems Engineer III in Austin, TX to ensure compliance with QMS requirements for medical devices. You will support harmonization, regulatory alignment with FDA 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971, and drive CAPA and risk management across sites.

The role emphasizes cross-functional collaboration, procedures development, and experience with SAP/EtQ ERP systems within a global QMS context.

Qualifications

• Extensive knowledge of global regulatory requirements for medical devices including 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971.
• Skilled in developing and implementing procedures for QMS elements incl. purchasing controls, design controls, CAPA and validation.
• Familiar with quality tools and methodologies (Six Sigma, root cause analysis, risk management, SPC, FMEA).
• Strong communication and collaboration across R&D and Regulatory stakeholders.
• Experience with enterprise quality systems and ERP (SAP, EtQ).
• Must have Medical Device experience, preferred SaMD and class II devices.

Responsibilities

• Support cross-functional teams in harmonization and standardization of quality procedures across sites.
• Complete gap assessments for local procedures against corporate requirements and medical device regulations.
• Collaborate to align and execute updates to local procedures with applicable requirements.

Skills

Regulatory knowledge

QMS implementation

CAPA

Six Sigma

Root cause analysis

Risk management

ISO 13485

ERP systems

Communication

Medical devices experience

Education

Bachelor's in Engineering

CQE certification

Tools

SAP

EtQ

Job description

Lancesoft seeks a Quality Systems Engineer III in Austin, TX to ensure compliance with QMS requirements for medical devices. You will support harmonization, regulatory alignment with FDA 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971, and drive CAPA and risk management across sites.

The role emphasizes cross-functional collaboration, procedures development, and experience with SAP/EtQ ERP systems within a global QMS context.