Quality Systems Engineer III

Accede Solutions Inc (accedesolution.com); Austin (TX); On-site; USD 100,000 - 160,000; Full time

Job summary

Accede Solutions Inc. in Austin, TX seeks an experienced Quality Systems Engineer III to lead the development, implementation, and continuous improvement of QMS within a medical device environment.

Ideal candidates will bring strong expertise in medical device quality, regulatory compliance, SaMD, and Class II devices, with knowledge of FDA and international standards. Collaboration with R&D, Regulatory, and cross-functional teams is essential to drive quality excellence.

Qualifications

• 5+ years of experience in Quality, Quality Systems, Regulatory Compliance, or a related field.
• Previous medical device industry experience is required.
• Strong knowledge of Quality Management Systems (QMS).
• Experience with medical device regulatory requirements, including:
• FDA 21 CFR Part 820
• ISO 13485
• ISO 14971
• EU MDR
• Experience with CAPA, nonconformance management, validation, risk management, FMEA, root cause analysis, SPC, and Six Sigma.
• Strong communication, collaboration, analytical, and problem-solving skills.
• Bachelor's degree in Engineering preferred; technical, engineering, or scientific background strongly preferred.
• Familiarity with Microsoft Office Suite.

Responsibilities

• Support the development, implementation, standardization, and continuous improvement of Quality Management Systems (QMS) across sites and regions.
• Ensure quality processes and procedures comply with applicable medical device regulations and corporate requirements.
• Perform gap assessments of local procedures against corporate standards, regulatory requirements, and applicable quality standards.
• Develop, update, and implement quality procedures, tools, and best practices.
• Support design controls, purchasing controls, validation, nonconformance management, and CAPA activities.
• Partner with cross-functional teams to implement QMS improvements and maintain regulatory compliance.
• Collaborate with R&D, Regulatory, Quality, and other stakeholders to drive alignment and effective execution.
• Support continuous improvement and harmonization of quality processes across global sites.

Skills

Quality Systems

Regulatory Compliance

QMS

CAPA

FMEA

Risk Management

ISO 13485

FDA 21 CFR Part 820

Medical Device

Communication

Education

Bachelor's degree in Engineering

Tools

EtQ

SAP

Microsoft Office

Job description

We are seeking an experiencedQuality Systems Engineer III to support the development, implementation, and continuous improvement of Quality Management Systems (QMS) within a medical device environment.

The ideal candidate will have strong experience in medical device quality, regulatory compliance, QMS, and Design Quality, with knowledge of FDA and international medical device standards. Experience with Software as a Medical Device (SaMD) and Class II medical devices is highly preferred.

Key Responsibilities

• Support the development, implementation, standardization, and continuous improvement of Quality Management Systems (QMS) across sites and regions.
• Ensure quality processes and procedures comply with applicable medical device regulations and corporate requirements.
• Perform gap assessments of local procedures against corporate standards, regulatory requirements, and applicable quality standards.
• Develop, update, and implement quality procedures, tools, and best practices.
• Support design controls, purchasing controls, validation, nonconformance management, and CAPA activities.
• Partner with cross-functional teams to implement QMS improvements and maintain regulatory compliance.
• Collaborate with R&D, Regulatory, Quality, and other stakeholders to drive alignment and effective execution.
• Support continuous improvement and harmonization of quality processes across global sites.

Required Qualifications

• 5+ years of experience in Quality, Quality Systems, Regulatory Compliance, or a related field.
• Previous medical device industry experience is required.
• Strong knowledge of Quality Management Systems (QMS).
• Experience with medical device regulatory requirements, including:
• FDA 21 CFR Part 820
• ISO 13485
• ISO 14971
• EU MDR
• Experience with CAPA, nonconformance management, validation, risk management, FMEA, root cause analysis, SPC, and Six Sigma.
• Strong communication, collaboration, analytical, and problem-solving skills.
• Bachelor's degree in Engineering preferred; technical, engineering, or scientific background strongly preferred.
• Familiarity with Microsoft Office Suite.

Preferred Qualifications

• Experience with Design Quality / Design Controls.
• Experience with Software as a Medical Device (SaMD).
• Experience with Class II medical devices.
• Experience with IEC 62304.
• Experience with enterprise quality systems such as EtQ and ERP systems such as SAP.
• CQE or equivalent certification.

Why This Role?

This is an excellent opportunity for a Quality professional to contribute to global QMS harmonization and continuous improvement within a medical device environment while partnering with R&D, Regulatory, and cross-functional teams.