Position Summary:

Manages Quality Engineering, including New Product Development Quality, Corrective and Preventive Actions, Temporary Deviations, Risk Management, Nonconforming Material, Material Dispositions, and Standards Management..

Essential Functions:

• Comply with miraDry Inc’s quality system requirements as well as any applicable regulatory requirements
• Comply with all health and safety regulations, policies, and work practices
• Efficiently manage Quality Engineering & Quality activities, including Quality Engineering, New Product Development Quality, Corrective and Preventive Actions, Temporary Deviations, Risk Management, Nonconforming Material, Material Dispositions, and Standards Management:
• Create and maintain process to manage updates to Standards and maintain State of the Art.
• Manage and maintain the Device Master Record (DMR)
• senior Quality and Manufacturing personnel with nonconforming material controls, material dispositions, Temporary Deviations, and participate on the Material Review Board
• the equipment management system, including reviewing specifications, qualifications, calibration, and maintenance
• and conduct defect awareness training for production and QC personnel
• and present quality trend analyses for reporting through quality system processes, including Management Reviews and Risk Management
• Perform incoming and in-process inspections, including miraDry system data reviews
• Generate and approve test protocols and reports, including design verification and validation, packaging and sterilization validation
• Create and approve instructions for rework activities
• Oversee software change controls and problem reporting
• Provide quality engineering support to product development, manufacturing, and service activities
• 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 and international regulation, guidance and standards applicable to company products
• Manage assigned projects including resource allocation, budgeting, and assuring adherence to schedules
• Participate in the short- and long-term planning of new product opportunities
• Participate in device risk and hazard analysis
• Actively work to promote team building and morale within the department and company
• Provide teammates with guidance for areas of responsibility.
• 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 5 years of Quality Engineering experience in the medical device industry.
• Experience with FDA Class II Medical Devices is required

Required Competencies:

• Documented training on the miraDry, Inc. quality system requirements as applicable
• Demonstrated knowledge of ISO/EN ISO 13485, ISO/EN ISO 14971, MDD 93/42/EEC, EU MDR 2017/745, CMDR, US 21 CFR Parts 803, 806, and 802, Australian TGA Regulations, Brazil ANVISA Resolution – RDC 16, Japanese PMD Act requirements, SOR/98-282: Canadian Medical Devices Regulations (latest consolidated version).
• Knowledge of US and international, 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.

*Salary is dependent on experience

FLSA Status: Exempt