Remote Quality Systems & Digital Engineer

Teleflex; Templeton (MA); 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 drive digital Quality workflows globally. This role collaborates with Quality, IT, and vendors to ensure validated, compliant systems across the organization.

The candidate will develop validation strategies, maintain documentation, and support analytics, dashboards, and data governance to improve quality outcomes and regulatory readiness. Remote in the US, preference for ET/CT zones.

Qualifications

• Bachelor’s degree required in a technical field.
• 3+ years of experience in Quality Systems or a related function within a regulated industry.
• Working knowledge of 21 CFR Part 11, FDA QMSR, and ISO 13485.
• Familiarity with CSA, CSV, GAMP 5, and risk-based validation.
• Experience supporting computerized systems within a Quality or regulated environment.

Responsibilities

• Own CSV/CSA activities for eQMS and other Quality systems.
• Develop risk-based validation strategies and documentation.
• Coordinate testing for new systems and changes.
• Maintain validated state across lifecycle and address deviations.
• Support audit readiness for validation records and quality systems.

Skills

Analytical skills

Technical writing

Cross-functional collaboration

Data analysis

Education

Bachelor’s degree in Engineering, CS, IS, Quality, Life Sciences, Data Analytics

Tools

CSV/CSA knowledge

GAMP 5

21 CFR Part 11

QMS basics

Job description

Ingenyx is seeking a Quality Systems & Digital Quality Engineer to lead CSV/CSA activities and drive digital Quality workflows globally. This role collaborates with Quality, IT, and vendors to ensure validated, compliant systems across the organization.

The candidate will develop validation strategies, maintain documentation, and support analytics, dashboards, and data governance to improve quality outcomes and regulatory readiness. Remote in the US, preference for ET/CT zones.