The Quality Engineer is responsible for providing support to the QC Engineering Manager and team. This position conducts Engineering related tasks and activities focused on non-conforming material, establishing effective inspection methods, resolving supplier quality issues, and working with Product Development to establish effective product testing, validation, and inspection processes. This person will also assist in the implementation of appropriate systems, policies, and procedures to ensure quality and compliance and proactively develop improved processes.

Responsibilities

• Develop, Document, and Maintenance of test systems for Myomo’s core products.
• Conduct Product Testing as required.
• Conduct RMA investigations and Root-Cause Analysis.
• Perform Qualification of product component replacements and substitutes.
• Facilitate Supplier Qualifications.
• Help execute Mfg. process Validations and Testing.
• Documentation of test procedures.
• Write ISPEC’s for components for various product lines.
• Conduct and support investigation of NCMR’s, CAPA’s, SCAR’s.
• Develop and implement effective corrective actions.
• Execution of Software Validation/ Fixture Qualifications.
• Assist QC Engineering Manager with various quality tasks.

Qualifications

• BS or equivalent in related Engineering discipline
• 1 year of professional experience required; 2+ years preferred. 
• Experience with Test Development and Documentation
• Software QA testing or fixture testing.
• Basic circuit analysis and electronic assembly skill including soldering and components identification.
• Basic mechanical assembly including being able to work from an assembly drawing.
• Attention to detail and ability to follow written instructions.
• Ability to learn new skills and adapt within a fast-paced environment.

Preferences

• Computer Science or Electrical Engineering Coursework.
• Medical Device GMPs and working in a regulated environment.
• Knowledge and use of basic statistics
• CAD/SolidWorks.
• Attention to detail and ability to follow written instructions.
• Experience with Basic Circuit Analysis.

• Certified Quality Engineer