Reports to: Director, Quality
Location: On-site in Madison Lab
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 non-conformances and complaints. Analyze and reports on product performance relative to quality goals. Conducts Quality Control functions for incoming material. Maintains the equipment calibration program.
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.
- 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.
- Ensures products meet the organization’s and customer quality and product integrity requirements.
- Supports product development and 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 improvements to products and new product development.
- Oversees product and manufacturing changes (Change Control) and evaluates for impact on product, processes and risks.
- Coordinates and conducts supplier audits, as needed, 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.
- Collaborates with other engineers, designers, and staff to review the project’s design, manufacturing, and test documentation (Device History Records); ensures quality requirements are met.
- Participates in the product development process to assure products are designed in compliance with FDA regulations and applicable international quality systems standards
- Monitors and manages customer feedback system.
- Investigates non-conformances / 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 Quality Management (e.g., Quality Review)
- Analyzes program quality and initiates corrective / preventive actions when necessary.
- Maintains knowledge of relevant quality and regulatory standards and augments quality system processes to meet changing requirements, including the (EU) Medical Device Regulation, US FDA, and others as required.
- 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, and Third Party Surveillance Audits, as required.
- Participates in the investigation and disposition of nonconforming material (MRB) to ensure product quality, as required.
- Participates, as needed, in design verification, including protocol development, execution and test report generation.
- Assists with the supplier qualification and monitoring.
Qualifications / Requirements / Experience
- BSc, Engineering,
- Preferred, ISO 13485:2016, Lead Auditor Certification
- Must have 5+ years related experience as a Quality Engineer, with at at least 3 years in the medical device industry
- Medical Device experience should include FDA 21 CFR Part 820 and ISO 13485:2016
- Familiarity with the following Standards
- 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.
- Proficient with Microsoft Office Suite
- Experience with ISO 13485:2016 quality system maintenance
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.