Quality Engineer - Madison, WI
The Quality Engineer advises 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. Evaluates and advises 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.
- Reviews design plans, process procedures, test procedures, and quality manuals to understand the scope, requirements, and function of products.
- 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.
- 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.
- Monitor and manage customer complaint management system.
- Investigates nonconformances / customer complaints down to the root cause; recommends, initiates and/or implements corrective / preventive actions.
- Participates in the analysis and disposition of non-conforming material to ensure product quality, as required.
- 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.
- Coordinates and conducts audits throughout the supply chain, ensuring quality standards, safety and legal requirements, and company policies and specifications are met
- Collaborates with other engineers, designers, and staff to review the project’s design, manufacturing, and test documentation; ensures that program or contract quality requirements are met.
- Analyzes program quality and initiates corrective actions when necessary.
- 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.
- 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.
- Provides training and support to employees on all quality concerns, customer complaints and application of quality methodologies.
- Assures component quality through supplier audit and data review.
- Performs other related duties as assigned.
Qualifications / Requirements/Experience
- Bachelor’s degree in Engineering, MBA preferred
- ISO 13485:2016 or ISO 9001:2015 Lead Auditor Certification
- Must have a minimum of 7 years of experience as a Quality Engineer manufacturing environment in the medical device industry.
- Medical Device Experience including FDA 21 CFR Part 820 and ISO 13485:2016 (MDSAP)
- Knowledge of Medical Device Manufacturing processes, procedures, tooling and equipment
- 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
- 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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