Quality Engineer

Position Summary:

Responsible for Quality Engineering activities, including New Product Development Quality, Corrective and Preventive Actions, Deviations, Risk Management, Nonconforming Material, Material Dispositions, incoming Inspection, Complaint Investigations, Failure Analysis, and Equipment Management.

Essential Functions:

• Comply with Spiro Robotics’ quality system requirements as well as any applicable regulatory requirements
• Comply with all health and safety regulations, policies, and work practices
• Manage Quality Engineering & supporting activities, including Quality Engineering, New Product Development Quality, Corrective and Preventive Actions, Deviations, Risk Management, Nonconforming Material, Material Dispositions, and Standards Management:
• Manage and maintain the Medical Device File (DMR)
• Review service records for approval
• Manage LHR review and approval process
• Develop, review and approve test protocols and reports
• Assist cross-functional personnel with nonconforming material controls, material dispositions, Deviations, complaints, CAPAs, Deviations, Risk Management, and incoming inspection.
• Manage the equipment management system, including reviewing specifications, qualifications, calibration, and maintenance
• Schedule and conduct Quality System awareness training and New Hire training.
• Prepare and present quality trend analyses for reporting through quality system processes, including Management Reviews and Risk Management
• Perform incoming and in-process inspections, and document results.
• Generate and approve test protocols and reports, including design verification and validation, packaging and sterilization validation
• Create and approve instructions for rework activities
• Provide quality engineering support to product development, manufacturing, complaint, and service activities
• Develop and manage the failure analysis lab for device returns
• Make decisions related to product quality and release
• Assess current practices against external standards, regulations, and guidance documents
• Perform internal and supplier quality audits
• Manage the risk management program, and participate in device hazard and risk analyses
• Maintain current knowledge of FDA, ISO 13485, ISO 14971, and other applicable regulations, guidance and standards applicable to Spiro Robotics
• Participate in device risk and hazard analysis
• Coordinate activities with other team members to ensure compliance with protocols, company standard operating procedures and regulatory authority requirements
• Perform other duties as assigned
• Travel: up to 10%, domestic and international

Education and /or Experience:

• Bachelor's Degree in Engineering field
• Minimum 2+ years of Quality Engineering experience in the medical device industry.
• Experience with FDA Class II Medical Devices with software is required

Required Competencies:

• Demonstrated knowledge of ISO/EN ISO 13485, ISO/EN ISO 14971, and SOR/98-282: Canadian Medical Devices Regulations (latest consolidated version).
• Knowledge of US medical device regulatory requirements
• Demonstrated ability to apply risk management techniques
• Demonstrated knowledge of word processing and spreadsheet programs.
• Requires creative, problem-solving ability Team oriented, the ability to work in small team environment is essential; must also be a self-starter with the ability to work independently
• Good planning and organization skills are vital. Strong critical thinking and problem-solving skills
• Ability to manage multiple priorities
• Effective verbal and written communication skills are essential.

FLSA Status: Exempt