Medical Device QA Engineer: CAPA & QMS Lead

Paycom; Brisbane (CA); On-site; USD 85,000 - 125,000; Full time

Job summary

Paycom is seeking a Quality Assurance Engineer to ensure QMS compliance with 21 CFR Part 820, ISO 13485:2016, EU MDR, MDSAP, and related standards. You will maintain CAPA systems, lead validation efforts for quality system software, and collaborate across cross-functional teams to drive improvements.

The role involves handling CAPA reviews, supplier quality activities, internal audits, and quality metrics tracking, with emphasis on precise documentation and timely corrective actions.

Qualifications

• Bachelor’s degree in Science, Engineering, or related field.
• 1-3 years of experience in a highly regulated medical device environment.
• Familiarity with 21 CFR Part 820, ISO 13485:2016, and 21 CFR Part 11.
• Experience with CAPA, customer complaints, internal audits.

Responsibilities

• Support the QMS compliance with regulatory standards.
• Maintain and improve SOPs, forms, and documentation.
• Manage customer complaint investigations from intake to closure.
• Lead CAPA investigations and monitor effectiveness.
• Support supplier quality activities and supplier audits.
• Assist with software validation and non-product software validation.

Skills

CAPA

QMS documentation

Root cause analysis

Regulatory compliance

Quality metrics

Cross-functional collaboration

Education

Bachelor’s degree in Science/Engineering

Tools

Microsoft Office

PLM systems

ERP systems

Job description

Paycom is seeking a Quality Assurance Engineer to ensure QMS compliance with 21 CFR Part 820, ISO 13485:2016, EU MDR, MDSAP, and related standards. You will maintain CAPA systems, lead validation efforts for quality system software, and collaborate across cross-functional teams to drive improvements.

The role involves handling CAPA reviews, supplier quality activities, internal audits, and quality metrics tracking, with emphasis on precise documentation and timely corrective actions.