Quality Engineer

SUMMARY OF POSITION:

The Quality Engineer participates and assists in developing, applying and implementing methods, tools, standards and practices to achieve product quality goals and requirements in the areas of design, development, production, distribution, maintenance and service. Actively contributes to new product teams and functional areas in Design Assurance, Verification & Validation, Purchased Material Quality, Test Method Development, Statistical Techniques, Process and Product improvements, and Risk Management. Investigates nonconformances and complaints.  Analyzes and reports on product performance relative to quality goals. 

Physical presence at the Beyond Air worksite is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.   

ACCOUNTABILITIES / ACTIVITIES:

• Monitors and manages customer complaint management system.
• Investigates nonconformances / customer complaints down to the root cause; recommends, initiates and/or implements corrective / preventive actions.
• Implements Quality Systems metrics and evaluation processes. Reporting of these metrics to Beyond Air management team (e.g., Management Review)
• Oversees data collection and analysis from various sources to identify trends in product quality or defects with the goal of mitigating and preventing recurrence and future defects.
• Analyzes program quality and initiates corrective actions when necessary. 
• Maintains knowledge of relevant quality and regulatory standards and augments quality system processes to meet changing requirements, including the Medical Device Regulation, US FDA, MDSAP, and others as required.
• Implements & maintains policies and procedures to ensure continuous compliance of our Quality Management System.
• Provides training and support to employees on all quality concerns, customer complaints and application of quality methodologies.
• Ensures products meet the organization’s and clinician’s, patient’s quality and product integrity requirements.
• Supports product development or operations team by providing analysis and expertise throughout the design and development process.
• Implements methods and systems to assure that Beyond Air development, manufacturing and clinical teams receive support in the areas of risk management, design controls including validation and verification testing, corrective and preventative action, root cause analysis, statistical analysis, quality planning and inspection processes.
• Implements quality strategies for modified and new product development.
• Oversees product and manufacturing changes (Change Control) for compliance with applicable regulations and potential impact on future and current regulatory submissions.
• Coordinates and conducts audits throughout the supply chain, ensuring quality standards, safety and legal requirements, and company policies and specifications are met
• Assures component quality through supplier audit and data review.
• Performs internal audits on QMS processes to ensure compliance to specifications and regulatory requirements.
• Performs Incoming Inspection Duties for components and finished product as required.
• Participates in Customer Quality System Audits, Third Party Surveillance Audits, and Management Review Meetings, as required.
• Participates in the analysis and disposition of nonconforming material to ensure product quality, as required.
• Collaborates with other engineers, designers, and staff to review the project’s design, manufacturing, and test documentation (Device History Records); ensures that program or contract quality requirements are met.
• Assists in drafting design plans, process procedures, test procedures, and quality manuals to understand the scope, requirements, and function of products.
• Assists Design & Development team in identifying customer requirements and ensures the project fulfills those requirements. 
• Supports assigned project or operations team by providing analysis and expertise throughout the inspection and implementation process.
• Participates in the product development process to assure products are designed in compliance with FDA regulations and applicable international quality systems standards
• Participates as needed in design verification, including protocol development, execution and test report generation.
• Assists with the supplier qualification and monitoring including conducting supplier audits. 

REQUIREMENTS / EXPERIENCE / EDUCATION

• Degree in Engineering,
• Must have ISO 13485:2016 or ISO 9001:2015 Lead Auditor Certification
• Must have 7+ years related experience as a Quality Engineer, with at at least 4 years in the medical device industry
• Medical Device experience should include FDA 21 CFR Part 820 and ISO 13485:2016 (MDSAP)
• Familiarity with the following Standards
  • Medical Electrical Equipment standards (IEC 60601)
  • Software Development per IEC 62304
  • Human Factors & usability engineering for Medical Devices
• Knowledge of Core Toos (SPC, FMEA, Control Plans)
• Excellent verbal and written communication skills
• Excellent interpersonal skills with ability to serve as a liaison between developers, project managers and customer support.
• excellent organizational skills with attention to detail.
• Achievement in lean Six Sigma a plus
• Proficient with Microsoft Office Suite
• Experience with ISO 13485:2016 quality system maintenance

Reports to

Director, Quality

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.