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QA Design Compliance Engineer

Company: Yoh, A Day & Zimmermann Company
Location: Littleton
Posted on: February 25, 2021

Job Description:

QA Compliance Design Engineer-Medical Devices needed for a contract opportunity with Yoh's client located in Rochester, NY.

What You'll Be Doing:

In this key role, you will be a core team member on New Product Development teams, taking projects from Concept to full production and implement necessary controls to ensure successful launch. You will partner with Product Development Engineering teams located at multiple domestic and international sites to ensure success of new product launches and changes to existing products.

Job Duties:

Develop new product quality control plans across multiple product lines while providing direction and consultation for implementation of quality process control plans to Product Design Engineers, Process Design Engineers, Quality Engineers and Supplier Engineers.
Act as the lead Quality Expert as member of New Product Development Team(s) to assure that all quality deliverables are completed on time
Train and Coach others in APQP techniques and in the use of scientific approaches including statistical tools
Audit New Product Development phase gate deliverables for regulatory and procedural compliance
Identify and drive execution on opportunities for improvement of new product launches based on historical like products




BS degree required
Knowledge of quality continual process improvement techniques in a Lean manufacturing environment and in statistical waste reduction techniques
Solid Technical Experience in driving quality improvement projects both internally and with suppliers
Knowledgeable in advanced data collection, measuring, analysis, improvement and control
Strong knowledge of manufacturing processes (assembly, weld, metal forming, paint, electrical assembly) and quality control methodologies and documentation
Working experience with the FDA Quality System Regulation (21CFR820), ISO 9000, ISO 13485 quality standards
Knowledgeable of Advanced Product Quality Planning techniques and tools
Experience in medical device industry and products a plus
Manufacturing or biomedical assessment activities strongly preferred
SQ Quality Engineer Certification desirable

What's In It For You?

  • This is a unique opportunity to support our client; one of the world's largest biomedical manufacturing companies and a provider of biotech product solutions. Medical benefits and 401K are available.

    Get Hired, Apply Now! Send WORD resumes to

    Recruiter: Lisa Hughes

    Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more !

    Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit to contact us if you are an individual with a disability and require accommodation in the application process.PandoLogic. Keywords: Compliance Engineer, Location: Littleton, MA - 01460

Keywords: Yoh, A Day & Zimmermann Company, Boston , QA Design Compliance Engineer, Engineering , Littleton, Massachusetts

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