Senior Quality Engineer

Title: Quality Engineer IV – Medical Devices

Location: St. Petersburg, FL (Onsite)

9+ month contract

Industry: Medical Devices / Healthcare Technology

Rate: TBD

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.
• 5+ 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.