The primary purpose of this position is to support the Super Brush Quality Management and Regulatory Systems. The Quality / Project Engineer is responsible for practicing and promoting compliance to all applicable forms, work instructions, and standard operating procedures in compliance with the QMS, ISO 9001 and ISO 13485. The Quality / Project Engineer may serve as the Quality Manager back-up, as required.
Essential Duties and Responsibilities:
Responsible for seeing that all tasks are performed in a manner that complies with the Super Brush LLC Quality Management System, ISO 9001 and ISO 13485 requirements
Write and manage new product documentation
Lead new product project teams
Write, execute and report validation documentation
Write and implement new test methods, as applicable
Perform/support quality investigations using problem solving skills (5 Why’s, Fishbone, Etc.)
Review and process all quality documentation following GDP requirements
Lead/support internal audits, as required
Effectively train others in an effort to promote QMS, ISO9001 and ISO 13485, in a positive manner
Other duties, as assigned
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form
Ability to deal with problems involving general concrete variables in standardized situations
Must have the ability to accept and work with constant change
Must possess strong attention to detail, commitment to task, customer focus, and be self-driven
Bachelor’s degree in engineering or Science related field
3-5 years medical device manufacturing related experience
Experience must also include 21CFR820, ISO 9001 and ISO 13485, validation, customer complaints, CAPA’s, RCA and Lean/Sigma
Must have New Product Development Technical Documentation Writing and Project Management Experience
Located in Springfield, MA, Super Brush LLC, a 65+ year old foam swab technology company, is a global market leader in the development and manufacture of foam swabs for medical device, clean room, cosmetic, and other applications. We are the leader in advanced foam technology and its applications to a variety of industries.
Behind our innovations stands an ISO vertically integrated manufacturing facility that allows us to deliver quality and consistency to our valued customers. Super Brush LLC is registered with the FDA as a medical device manufacturer.
Super Brush LLC is NQA ISO 9001 Registered and ANAB Accredited.
Super Brush LLC offers a comprehensive benefits package including:
employer-paid short term disability insurance
employer-paid long term disability insurance with voluntary option
employer-paid basic life insurance with voluntary option
employee assistance program
paid vacation time
paid sick time
One of Super Brush LLC's fundamental principles is Equal Employment Opportunity. Employment at Super Brush LLC is based upon abilities and qualifications without discrimination because of race, color, religion, gender, sex, national origin, age, disability, genetic information, veterans' status or any other status or condition that is protected by applicable state law.
Super Brush LLC started as a family owned and operated manufacturing company more than 50 years ago. As unique suppliers of premium quality foam tipped applicators and brushes to the cosmetic industries, Super Brush continually looked for opportunities to diversify into new and exciting fields.
Embarking on the challenging fields of medical disposable applications and clean room industries,... Super Brush developed a full range of multi-purpose swabs and applicators. In 2004, in addition to our standard line of medical foam probes, applicators and swabs, Super Brush added a number of unique and practical medical foam applicators, probes, and medical foam brushes, each specially designed for use in chemical and drug application, cell collection, forensic evidence collection and processing, probing, adhesive applications and endoscope cleaning.
Behind our innovations stands an ISO vertically integrated manufacturing facility that allows us to deliver quality and consistency to our valued customers. Super Brush is registered with the FDA as a medical device manufacturer.
Super Brush is NQA ISO 9001 Registered and ANAB Accredited.