Quality Engineer

Department: Quality

Employment Type: Full Time

Location: Burlington, MA

Compensation: $90,000 - $100,000 / year

Description

The Quality Engineer provides support to the QC Engineering Manager and team. The core aspects of this role are to focus on non-conforming materials, establish effective inspection methods, resolve supplier quality issues, and collaborate with Product Development to deliver effective product testing, validation, and inspection.

He/she will also assist in the implementation of appropriate systems, policies, and procedures to ensure quality and compliance and proactively develop improved processes.

The ideal candidate is a well-organized, process-oriented, and systematic-minded professional who is able to keep an eye toward process improvements and innovation. Keys to success in this role include the ability to demonstrate attention to detail as well as the capability to both collaborate effectively and work independently. He/she will be able to understand and incorporate the viewpoints of cross-functional stakeholders.

Responsibilities

Develop, document, and maintain 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.

Requirements

Bachelor's degree in a related Engineering discipline with 1+ year of experience. (2+ years' professional experience preferred)
Experience with test development and documentation.
Basic mechanical assembly including being able to work from a drawing.
Experience with basic circuit analysis.
Fundamental electronic assembly skill level including soldering, and components identification.
Software QA testing or fixture testing.
Attention to detail and ability to follow written instructions.
Ability to learn new skills and adapt to a small rapidly changing team.

Preferred:

Computer Science or Electrical Engineering Coursework.
Medical Device GMPs and working in a regulated environment.
Knowledge and use of basic statistics.
CAD/Solidworks.
Quality Engineer certification.

Applied

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Offer