Quality Engineer - Madison, WI
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.
Quality Management System (40%)
- 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.
Design and Development (40%)
- 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.
Supplier Management (20%)
- 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.
Qualifications / Requirements/Experience
- Bachelor’s degree in Engineering, Masters preferred
- Must have 5+ years experience as Quality Engineer in Pharma or Biotech
- Medical Device Experience including FDA 21 CFR Part 820
- Familiarity with Medical Electrical Equipment standards such as IEC 60601, Software Development per IEC 62304
- Human Factors and usability engineering for Medical Devices
- Knowledge of core tools, (SPC, FMEA, Control Plans)
- Excellent verbal and written communication skills.
- Excellent interpersonal skills with ability to serve as a liaison with developers, project managers and customer support.
- Excellent organizational skills and attention to detail.
- Achievement in lean/Six Sigma environment
- Strong analytical and problem-solving skills.
- Thorough understanding of or the ability to quickly learn about the project or product being developed.
- Proficient with Microsoft Office Suite or related software.
- Experience with ISO 13485:2016 quality system maintenance
- Experience with MDSAP a plus
- Reports to the Director, Quality Assurance
- Based in Madison, WI
- Monday – Friday, 9am – 5pm
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.
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