Lead Quality Engineer, Medical Devices & Compliance

Ascendo-Resources; Saint Petersburg (FL); On-site; USD 76,000 - 94,000; Full time

Benefits offered by this job

Onsite role

Job summary

Ascendo-Resources is seeking a Quality Engineer IV for a 9+ month contract in St. Petersburg, FL. You will provide quality leadership across medical device development, ensure regulatory compliance, and guide cross‑functional teams in risk management and design controls.

The role requires hands‑on V&V, CAPA, and documentation expertise, with a focus on FDA 21 CFR Part 820, ISO 13485/14971, and Part 11. onsite collaboration with engineering and manufacturing partners.

Qualifications

• Minimum 4+ years in medical device quality engineering or design assurance.
• Hands‑on experience with design controls, DHF/DMR, and regulatory file maintenance.
• Familiarity with FDA 21 CFR Part 820, ISO 13485, and ISO 14971.

Responsibilities

• Lead quality activities across product development, changes, and lifecycle management.
• Ensure compliance with FDA, ISO standards and 21 CFR Part 11 electronic records.
• Review design inputs/outputs, risk documents, and traceability across specs.
• Develop and approve V&V plans, protocols, and reports; ensure data integrity.
• Support design transfer, manufacturing readiness, and supplier qualification.
• Lead CAPA investigations and drive corrective actions.
• Provide technical guidance to engineering teams on quality requirements.

Skills

Quality engineering

FDA regulations

ISO 13485 / ISO 14971

Design controls

V&V (verification & validation)

Risk management

CAPA & nonconformance

Cross‑functional leadership

Documentation & traceability

21 CFR Part 11 knowledge

Education

Bachelor's degree in Biomedical, Mechanical, Electrical, Systems, Software, Quality Engineering

Tools

Minitab

eQMS

PLM platforms

Job description

Ascendo-Resources is seeking a Quality Engineer IV for a 9+ month contract in St. Petersburg, FL. You will provide quality leadership across medical device development, ensure regulatory compliance, and guide cross‑functional teams in risk management and design controls.

The role requires hands‑on V&V, CAPA, and documentation expertise, with a focus on FDA 21 CFR Part 820, ISO 13485/14971, and Part 11. onsite collaboration with engineering and manufacturing partners.