Quality Systems Engineer III

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

Title: Quality Systems Engineer III Location: Austin, TX 78744 Duration: 10/26/2026 to 02/28/2027 Duties: Job description: Responsible for ensuring compliance with established requirements and standards for products and processes through effective implementation of the Quality Management System (QMS). The position is responsible for supporting the global development, implementation, and continuous improvement and harmonization of the local Quality Management System (QMS) in compliance with applicable medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304 and EU MDR as well as corporate procedures and requirements. What You Can Expect How You'll Create Impact

Principal Duties and Responsibilities:

• Support cross-functional teams in the harmonization and standardization of quality procedures, tools, and best practices across sites and regions.
• Complete gap assessments for local procedures against corporate procedures, requirements and applicable medical device regulations and standards.
• Collaborate with cross functional team members to align & execute updates to local procedures to align with applicable requirements.

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

Skills:

What Makes You Stand Out Expected Areas of Competence (i.E., knowledge, skills and abilities)

• 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 various QMS elements including but not limited to purchasing controls, design controls, nonconformance management, validation, and corrective and preventive actions (CAPA).
• Familiarity with quality tools and methodologies (e.G., Six Sigma, root cause analysis, risk management, SPC, FMEA).
• Strong communication and collaboration skills, with the abilityto influence and drivealignment acrossdiversestakeholders(R&DandRegulatory).
• Preferred experience with enterprise quality systems and ERP systems (e.G., SAP, EtQ).
• Must have previous Medical Device ExperiencePreferred experiencewithSaMD(Softwareasamedicaldevice)andclassIImedicaldevices.

Education:

Your Background Education/ExperienceRequirements

• High school diploma or equivalent required.
• Bachelor s degree in Engineering preferred.
• Technical engineering, and/ or scientific background is strongly preferred.
• Minimum 5+ years of experience in Quality/Regulatory Compliance or related field required CQE or equivalent certification preferred.
• Must be familiar with Microsoft Office Suite.