Quality Engineer - Medical Devices

Role Overview:

You will be a part of the core project team and support quality engineering throughout the entire development cycle. Your responsibilities will include leading product risk management, usability, reliability, and design validation efforts for new product development and design change projects. Additionally, you will lead the development and implementation of design verification and validation plans with the project design lead.

Key Responsibilities:

• Lead product risk management, usability, reliability, and design validation efforts
• Develop and implement design verification and validation plans
• Develop Critical to Quality (CTQs), design input, and output documents
• Lead fixture qualification and test method validation
• Implement tools like Design of Experiments (DOEs), FMEA sessions, Risk Management, and ensure compliance to CTQs and safety requirements
• Manage electronic document control and version control for all project-related documents
• Ensure adherence to quality systems and design assurance SOPs
• Lead usability, reliability, testing, verification, and validation testing
• Provide statistical testing and reliability plans
• Provide quality and regulatory compliance guidance to product development or design change project teams
• Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed
• Co-Lead CAPA efforts and apply systematic problem-solving methodologies
• Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics

Qualifications Required:

• QMS Knowledge of Regulatory standards CFR820, ISO 13485 & 14971, 60601
• Hands-on experience in Risk Management
• Good understanding of Post Market Survey and complaint handling
• Design plan Medical Process DQC Deviation and CAPA preferred

(Note: Any additional details of the company were not specified in the job description) Role Overview:

You will be a part of the core project team and support quality engineering throughout the entire development cycle. Your responsibilities will include leading product risk management, usability, reliability, and design validation efforts for new product development and design change projects. Additionally, you will lead the development and implementation of design verification and validation plans with the project design lead.

Key Responsibilities:

• Lead product risk management, usability, reliability, and design validation efforts
• Develop and implement design verification and validation plans
• Develop Critical to Quality (CTQs), design input, and output documents
• Lead fixture qualification and test method validation
• Implement tools like Design of Experiments (DOEs), FMEA sessions, Risk Management, and ensure compliance to CTQs and safety requirements
• Manage electronic document control and version control for all project-related documents
• Ensure adherence to quality systems and design assurance SOPs
• Lead usability, reliability, testing, verification, and validation testing
• Provide statistical testing and reliability plans
• Provide quality and regulatory compliance guidance to product development or design change project teams
• Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed
• Co-Lead CAPA efforts and apply systematic problem-solving methodologies
• Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics

Qualifications Required:

• QMS Knowledge of Regulatory standards CFR820, ISO 13485 & 14971, 60601
• Hands-on experience in Risk Management
• Good understanding of Post Market Survey and complaint handling
• Design plan Medical Process DQC Deviation and CAPA preferred

(Note: Any additional details of the company were not specified in the job description)