Job Description
Title: Quality Engineer IV – Medical Devices
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Location: St. Petersburg, FL (Onsite)
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9+ month contract
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Industry: Medical Devices / Healthcare Technology
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Rate: TBD
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Position Overview
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- 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.
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Key Responsibilities
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Design Quality & Regulatory Compliance
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- 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.
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Verification, Validation & Risk Management
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- 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.
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Design Transfer & Quality Systems
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- 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.
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Technical Leadership
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- 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.
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Required Qualifications
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- 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.
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Preferred Qualifications
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- 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.
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