Quality Engineer IV

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

Title: Quality Engineer IV – Medical Devices

Location: St. Petersburg, FL (Onsite)
9+ month contract

Industry: Medical Devices / Healthcare Technology

Rate: $55 - $68/hr w2

Position Overview

• We are seeking an experienced Quality Engineer IV to provide quality leadership across medical device product development, design assurance, and lifecycle management activities.
• This position will serve as the Quality representative on cross‑functional engineering teams, ensuring compliance with FDA regulations, ISO 13485, ISO 14971, and applicable medical device quality standards.
• The ideal candidate will have hands‑on experience with medical device design controls, risk management, verification, and validation (V&V), design transfer, and regulatory compliance, along with strong technical and cross‑functional leadership skills.

Key Responsibilities

Design Quality & Regulatory Compliance

• Lead quality activities throughout medical device product development, design changes, and lifecycle management.
• Ensure compliance with FDA 21 CFR Part 820 (QMSR), ISO 13485, ISO 14971, and applicable regulatory requirements.
• Review and approve design inputs, outputs, design reviews, risk management documentation, and design control deliverables.
• Maintain requirements traceability across product specifications, risk controls, and verification and validation activities.
• Ensure electronic quality and design records comply with 21 CFR Part 11 requirements.

Verification, Validation & Risk Management

• Develop, review, and approve verification and validation plans, protocols, reports, and test methods.
• Apply statistical techniques to sampling plans, acceptance criteria, capability studies, and engineering data analysis.
• Evaluate testing methodologies, equipment, and laboratory results to ensure accuracy, reliability, and compliance.
• Support product risk assessments and implementation of risk mitigation strategies.

Design Transfer & Quality Systems

• Support design transfer activities, manufacturing readiness, process validation, and production quality requirements.
• Collaborate with Engineering, Manufacturing, Supplier Quality, Regulatory Affairs, and external laboratories.
• Lead or support root cause investigations, nonconformance resolution, corrective and preventive actions (CAPA), and continuous improvement initiatives.
• Support supplier qualification, component changes, and product quality investigations.
• Participate in regulatory audits, technical documentation reviews, and quality system assessments.

Technical Leadership

• Provide technical guidance to engineering and product development teams on design assurance and quality requirements.
• Identify and communicate product quality, patient safety, and regulatory compliance risks.
• Collaborate with internal teams, customers, suppliers, and regulatory stakeholders.
• Drive improvements in quality processes, documentation, and engineering practices.

Required Qualifications

• Bachelor's degree in Biomedical, Mechanical, Electrical, Systems, Software, Quality Engineering, or a related technical discipline.
• 4+ years of experience in medical device quality engineering, design assurance, or product development quality.
• Strong hands‑on experience with medical device design controls and design history documentation.
• Demonstrated knowledge of ISO 13485, ISO 14971, and FDA 21 CFR Part 820 (QMSR).
• Working knowledge of 21 CFR Part 11, including electronic records, electronic signatures, and data integrity.
• Experience reviewing design inputs and outputs, requirements traceability, risk management files, and V&V documentation.
• Experience with design transfer, product changes, CAPA, nonconformance investigations, and quality management systems.
• Knowledge of statistical analysis, root cause analysis, and structured problem‑solving techniques.
• Strong technical documentation, communication, and cross‑functional collaboration skills.
• Ability to independently manage quality deliverables across multiple engineering projects.

Preferred Qualifications

• Experience with Class II or Class III medical devices.
• Background in electromechanical, software‑enabled, sterile, implantable, diagnostic, or combination‑product technologies.
• Familiarity with IEC 62304, IEC 62366-1, IEC 60601, ISO 11607, or ISO 10993 standards.
• Experience with Minitab, electronic Quality Management Systems (eQMS), or Product Lifecycle Management (PLM) platforms.
• Certifications such as ASQ Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), ISO 13485 Lead Auditor, or Six Sigma.