Quality Engineer (Med Device)

Position Overview
The Quality Engineer plays a key role in ensuring that our products, processes, and systems meet regulatory, customer, and internal quality standards. This role involves supporting quality management systems, driving continuous improvement initiatives, and working cross-functionally with engineering, operations, and regulatory teams.

Essential Duties and Responsibilities:
Design Controls

• Ensure compliance with design control requirements (21 CFR 820.30, ISO 13485) throughout product development
• Review and approve design inputs, outputs, verifications, validation, and design transfer deliverables
• Partner with R&D and product development teams to ensure requirements traceability from concept to commercialization

Risk Management

• Lead risk management activities per ISO 14971, including hazard analysis, FMEAs, and risk-benefit analyses
• Ensure risks are identified, mitigated, and documented throughout the design and development process

Verification & Validation

• Review and approve verification and validation protocols/reports to confirm adequacy of test plans and methods
• Ensure acceptance criteria are scientifically sound and aligned with user needs, regulatory requirements, and product specifications
• Oversee usability engineering and human factors validation, as applicable

Regulatory & Standards Compliance

• Interpret and apply regulatory requirements (FDA, EU MDR, Health Canada, TGA, etc.) and harmonized standards (ISO 10993, IEC 60601, IEC 62304, etc.) to design documentation
• Stay current on evolving standards and guidance documents relevant to medical device design and software

Cross-Functional Collaboration

• Act as quality liaison between R&D, clinical, regulatory, and manufacturing teams during product design
• Facilitate design reviews and ensure all stakeholders have provided appropriate input
• Support Design History File (DHF) compilation and readiness for regulatory submissions

Quality Systems & Compliance

• Maintain and improve the company’s Quality Management System (QMS) in compliance with ISO 13485, 21 CFR Part 820, and other applicable standards/regulations
• Support internal, external, and regulatory audits by preparing documentation and serving as a subject matter expert (SME)

Process Quality

• Develop, review, and approve validation protocols (IQ/OQ/PQ), test methods, and inspection procedures
• Analyze product performance data and implement corrective and preventive actions (CAPA)

Continuous Improvement

• Lead root cause investigations and apply structured problem-solving methodologies (e.g., 5 Why, Fishbone, FMEA)
• Drive process improvements to increase efficiency, reduce defects, and improve customer satisfaction
• Support supplier quality management, including supplier qualification, monitoring, and audits

Documentation & Reporting

• Generate clear, concise technical reports, nonconformance records (NCRs), and CAPA documentation
• Monitor and track quality metrics, reporting trends to management
• Ensure timely and accurate communication of quality issues to internal stakeholders and customers

Education and/or Work Experience Requirements:
Education and Experience

• Bachelor’s degree in engineering, Life Sciences, or related field
• 6+ years of experience in quality engineering with medical devices, pharmaceuticals, or other regulated industries

Technical Skills

• Knowledge of ISO 13485, FDA QSR (21 CFR 820), ISO 14971, and regulated regulatory frameworks
• Proficiency in root cause analysis, CAPA, and risk management tools
• Experience with statistical analysis, SPC, and problem-solving techniques
• Familiarity with validation, test methods, and quality inspection techniques

Soft Skills

• Strong attention to detail with excellent organizational and documentation skills
• Effective communication and collaboration skills across cross-functional teams
• Ability to work independently and manage multiple priorities in a fast-paced environment

Physical Requirements:

• Ability to lift up to 50 pounds
• Ability to stand for extended period of time, as applicable