Remote Design QA Engineer: CAPA & Compliance Leader

Theuniversityunion; San Diego (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

ECI is seeking a Design Quality Assurance Engineer to provide quality oversight and strategic leadership across the medical device lifecycle. You will ensure compliance with regulatory standards, collaborate with R&D, Quality, and Regulatory teams, and drive improvements in design processes and documentation.

The role supports 21 CFR 820.30, ISO 13485:2016, and ISO 14971:2019, with remote work and up to 25% travel to accommodate project needs. Strong communication and leadership are essential.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or Quality Management.
• 8+ years of experience in medical device design quality, design assurance, or development quality.
• Strong knowledge of FDA QSR (21 CFR 820), ISO 13485, ISO 14971, EN62304, MDSAP, and EU MDR/IVDR.
• Demonstrated experience managing Design Controls, Risk Management, and DHF maintenance.
• Experience supporting Regulatory Submissions (510(k), Technical Files, PMA).
• Familiarity with eQMS/PLM tools.
• Excellent communication, analytical, and leadership skills.
• ASQ CQE or Six Sigma certification preferred.

Responsibilities

• Provide quality and compliance input to project teams for decisions and deliverables.
• Support Risk Management planning and maintenance of product risk documentation.
• Support Usability Engineering and planning documentation.
• Provide independent quality oversight for design and development activities.
• Ensure Design Control compliance per 21 CFR 820.30 and ISO 13485:2016.
• Review DHF, Risk Management Files, and related documentation.
• Lead cross-functional Design Reviews ensuring traceability and risk alignment.
• Support MDSAP, MDR and ISO 14971:2019 compliance activities and audits.
• Collaborate with Regulatory Affairs to support submissions.
• Review and approve Verification & Validation plans and reports.
• Mentor and train teams on quality system and regulatory expectations.
• Drive continuous improvement and digital QMS/PLM enhancements.

Skills

Quality leadership

Regulatory knowledge

Design Controls

Risk Management

eQMS/PLM

Education

Bachelor’s or Master’s degree in Engineering, Life Sciences, or Quality Management

Tools

eQMS/PLM tools

Job description

ECI is seeking a Design Quality Assurance Engineer to provide quality oversight and strategic leadership across the medical device lifecycle. You will ensure compliance with regulatory standards, collaborate with R&D, Quality, and Regulatory teams, and drive improvements in design processes and documentation.

The role supports 21 CFR 820.30, ISO 13485:2016, and ISO 14971:2019, with remote work and up to 25% travel to accommodate project needs. Strong communication and leadership are essential.