Quality Engineer (Medical Device) – TeDan Surgical Innovations

Job Description

The Quality Engineer (QE) ensures the delivery of safe, effective, and compliant medical devices by applying technical expertise, data-driven decision-making, and cross-functional collaboration across the product lifecycle. This role focuses on building quality into products and processes, supporting regulatory compliance, and driving continuous improvement in manufacturing, post-market surveillance, and supplier performance.

Core Competencies

Quality & Regulatory Expertise

• Apply knowledge of ISO 13485, FDA QMSR, GMP/GDP, and Design Controls to ensure compliance across product development and sustaining activities.
• Manage complaint investigations, CAPAs, nonconformance events, and supplier corrective actions using structured root cause methodologies.
• Develop and maintain risk management documentation per ISO 14971, ensuring product and process risks are identified, mitigated, and monitored.

Analytical & Problem-Solving Skills

• Analyze quality, manufacturing, and supplier data to identify systemic issues, performance gaps, and improvement opportunities.
• Apply statistical and analytical methods (e.g., SPC, control charts, Pareto analysis, DOE, sampling plans, and process capability analysis) to assess and monitor process performance.
• Independently perform root cause investigations and drive sustainable corrective and preventive actions (CAPA).
• Develop and maintain automated or semi-automated dashboards, reports, and quality metrics (e.g., Power BI, Python) to improve visibility and reduce manual reporting effort.
• Identify trends and emerging quality signals, translating complex data into clear, actionable insights for Quality leadership and cross-functional stakeholders.
• Support management review and risk management activities through accurate, data-driven quality metrics and analyses.

Process & Product Excellence

• Evaluate engineering, process, and supplier changes for quality, validation, and post-market
• impact.
• Support process and software validation, including metrology systems, and execute verification/validation protocols.
• Drive continuous improvement initiatives in collaboration with Engineering, Manufacturing, and Supply Chain teams.

Supplier & Cross-Functional Collaboration

• Monitor and enhance supplier quality performance through audits, corrective actions, and scorecards.
• Serve as liaison between Quality and Engineering to ensure inspection methods, process capabilities, and design controls are properly implemented.
• Collaborate cross-functionally to resolve conflicts, prioritize actions, and communicate technical findings effectively.

5. Technical Communication & Documentation

• Prepare clear, concise technical documentation, including protocols, reports, procedures, and quality metrics.
• Ensure traceability of complaints, CAPAs, nonconformances, supplier events, and risk management records.

Project & Time Management

• Independently plan and manage multiple projects, balancing timelines, resources, and regulatory requirements.
• Demonstrate accountability for timely completion of quality initiatives with minimal supervision.

Qualifications

• 4–6 years of Quality Engineering experience in the medical device industry.
• Experience with complaint handling, CAPA, nonconformance investigations, supplier quality, and post-market surveillance.
• Strong understanding of manufacturing processes, supplier controls, inspection methods, and process capability.
• Proficiency in statistical analysis and quality tools (Excel required; Minitab preferred).
• Technical writing expertise for protocols, reports, and procedures.
• Working knowledge of Design Controls, human factors, and risk management.
• Excellent organizational, communication, and collaboration skills.

Education

• Bachelor of Science in Biomedical Engineering, Mechanical Engineering, or a related discipline.

Additional Requirements

• Occasional travel (5–10%).