Quality Engineer

About This Role

The Quality Engineer will develop, optimize, and maintain manufacturing processes to ensure high-quality production of single-use supplies, including medical device components, within a regulated industry.

Responsibilities

• Develop, optimize, and maintain manufacturing processes for high-quality production of single use supplies including medical device components
• Lead, document, and track FMEAs
• Coordinate suppliers and verify quality standards in accordance with industry and customer requirements
• Develop and implement supplier management programs
• Manage Supplier corrective actions
• Provide quality support in all aspects of the Product Life Cycle
• Conduct quality investigations (CAPA and NCR) and Material Review Board (MRB)
• Drive root cause corrective actions (RCCA) for quality issues
• Support 3rd party, customer, internal and external audits
• Develop Quality Assurance Plans with the participation of cross-functional teams
• Author validation protocols and reports

Requirements

• Minimum 4 years of prior relevant experience (Bachelor's degree) or minimum 2 years (Graduate degree) or 8 years (in lieu of degree)
• Hands-on experience in a manufacturing environment
• Strong background in process engineering, lean manufacturing, and quality systems within a regulated industry
• Knowledge and experience with quality tools such as CAPA, six sigma, lean manufacturing, PPAP, FMEA, problem solving techniques, and root cause analysis
• Proficient knowledge of ISO based Quality Management Systems
• Knowledge of Quality Engineering and Advanced Quality principles (Six Sigma methodology, Root Cause/Corrective Action, DMAIC, Design for Manufacturability)
• Proficient in understanding of engineering drawings, documentation, including dimensioning, and tolerance
• Experience working with project management and interfacing with customers
• Ability to write reports, business correspondence, and create project plans

Qualifications

• Bachelor’s Degree or Graduate Degree
• Minimum 4 years of prior relevant experience with a Bachelor's degree, or 2 years with a Graduate Degree, or 8 years in lieu of a degree.

Nice to Have

• Knowledge of plastic materials
• Mechanical engineering experience

Skills

* Required skills

Benefits