Quality Engineer II
Quality-Medical Device-BioConsulting Partners - Boston, MA

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Quality Engineer II – Medical Device
Boston, MA

Cutting Edge Technology, fast paced environment.
Are you looking for an opportunity in an innovative Medical Device organisation? We are small enough that you feel the impact of your contributions, but large enough to offer you financial stability and career development. Do you enjoy being exposed to all areas of Medical Device Quality? With a dynamic work environment, our teams have unusually strong personal chemistry and with double digit growth each of the past 5 years there are significant opportunities within. If you’re looking for an opportunity to build something that will last then we would like to hear from you.

The Opportunity:
The Senior Quality Engineer will be involved in all areas of Medical Device Quality and wear many hats. This broadly defined assignment will include Quality System development and maintenance and CAPA support. You will also represent Quality interests on project teams, including assisting with Design Controls. Other responsibilities include conducting supplier audits, participating in FDA audits, and supplier management. Their rapidly expanding organisation means there are significant opportunities for career development.

You must meet the criteria below for consideration:
-3+ years of related Medical Device Quality or FDA regulated industry experience.
-A Bachelor’s Degree in Science or Engineering.
-Competency in 21CFR 820, 21CFR 803, and 804.
-Must have at least 1 year of audit experience.
-Legally authorized to work in the U.S.
-ASQ certification preferred

The compensation plan includes an above-average base salary, a bonus program, and expanded benefits.

This is an entrepreneurial opportunity with a company that prides itself on its product offerings and corporate culture. If you are a motivated, self-starter who would like to help this organization grow, and if your background and qualifications meet these specifications, please respond.
Please E-mail your confidential resume (in Microsoft Word)


NO TELEPHONE CALLS PLEASE. Due to the high volume of resumes received, only applicants with specific experience requested by our clients will be contacted.

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