Quality Engineer

The Senior Quality Engineer is in the healthcare domain is a hybrid role that combines deep technical expertise in quality assurance with strategic program management skills. This role ensures that healthcare products, systems, and services are delivered to the highest standards of quality, compliance, and efficiency. Acting as a bridge between engineering, regulatory, and clinical stakeholders, the QEPM focuses on achieving program milestones while ensuring patient safety, regulatory compliance, and operational excellence.

Quality Assurance & Compliance

• Develop and Implement Quality Systems:
• Oversee product lifecycle processes, including design controls, validation, verification, and risk management.
• Regulatory Compliance:
• Support Q&R team in conducting internal and external audits to ensure adherence to healthcare regulations.
• Oversee documentation for regulatory submissions (e.g., FDA 510(k), CE marking).
• Defect Management:
• Identify and analyze defects through root cause analysis.
• Support product teams to implement corrective and preventive action plans (CAPA) and monitor their implementation.
• Continuous Improvement:
• Drive Lean Six Sigma initiatives to enhance product reliability, reduce waste, and optimize workflows.
• Implement quality improvements based on feedback from clinical teams and end-users.
• Continuous Improvement:
• Align quality objectives with organizational goals and patient-centric outcomes.
• Implement processes to manage risks like adverse events or non-compliance.
• Lead cross-functional teams (R&D, manufacturing, regulatory, clinical) to achieve quality and program milestones.
• Act as a liaison between engineering, operations, and quality assurance teams.
• Address risks related to quality and program delivery.

Technical Skills:

• Expertise in healthcare quality frameworks: ISO 13485, FDA 21 CFR Part 11/820, IEC 62304, EU MDR.
• Proficiency in quality tools: FMEA, CAPA, SPC, and Six Sigma methodologies.

Program Management Skills:

• Strong project management experience with tools like Microsoft Project, Jira, and Trello.
• Ability to lead cross-functional teams and manage complex programs.
• Risk management expertise, including proactive identification and mitigation.

Healthcare Domain Expertise:

• Understanding of clinical workflows and patient safety considerations.
• Experience with medical device development, imaging systems, or remote patient monitoring solutions.

Soft Skills:

• Leadership and team-building capabilities.
• Exceptional communication skills for technical and non-technical stakeholders.
• Problem-solving and analytical thinking to resolve challenges.