Remote Quality Systems & Digital Engineer | CSV & Data

Teleflex; Massachusetts; Remote; USD 87,000 - 109,000; Full time

Job summary

Ingenyx is seeking a Quality Systems & Digital Quality Engineer to lead CSV/CSA activities and validate Quality software across a global medical device organization. You will ensure compliance and lifecycle management for computerized systems, partnering with IT and vendors.

Reporting to the Quality Systems Manager, you will develop risk-based validation strategies, craft documentation, configure eQMS/ERP modules, and drive data-driven quality improvements across processes and deployments.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, or related field.
• 3+ years in Quality Systems, computerized validation, or digital quality in regulated industry.
• Working knowledge of 21 CFR Part 11, ISO 13485.
• Familiarity with CSA, CSV, GAMP 5, risk-based validation.

Responsibilities

• Own CSV/CSA activities for eQMS platforms and quality functions.
• Develop validation strategies based on risk and system use.
• Create, review, and maintain validation docs and traceability.
• Coordinate testing for systems, configurations, and changes.
• Maintain validated state throughout lifecycle.

Skills

CSV/CSA

QMS Digitalization

Quality data analytics

Regulatory compliance

Education

Bachelor’s degree in Engineering/Science

Tools

eQMS

ERP Quality

GAMP 5

Job description

Ingenyx is seeking a Quality Systems & Digital Quality Engineer to lead CSV/CSA activities and validate Quality software across a global medical device organization. You will ensure compliance and lifecycle management for computerized systems, partnering with IT and vendors.

Reporting to the Quality Systems Manager, you will develop risk-based validation strategies, craft documentation, configure eQMS/ERP modules, and drive data-driven quality improvements across processes and deployments.