Senior Quality Engineer - San Diego, United States - miraDry, Inc.

Description

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..

Do not wait to apply after reading this description a high application volume is expected for this opportunity.

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