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Quality Engineer-Medical Device-Waltham, MA

Company: Michael Page
Location: Waltham
Posted on: July 22, 2021

Job Description:

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.


The key responsiblities of the Quality Engineer are

* Develop, implement and maintain the company's quality systems in compliance with applicable ISO-13485, FDA, CE and other regulatory certification requirements as well as with internal policies and objectives

* Work with design engineers to establish quality specifications for all products and processes

* Ensure appropriate quality planning and procedures for new products, design changes and process modifications

* Establish tools to monitor quality processes and prepare reports of findings on a regular periodic basis and present at management review meetings

* Establish and implement appropriate methods such as design of experiments, sampling techniques and data analysis for products and processes

* Perform supplier qualifications

* Help resolve quality problems and product performance issues using sound engineering principles and problem solving techniques including root cause and economic analyses

* Ensure that inspection and approval of incoming materials and work-in-process is appropriate, in conformance with specifications and adequately documented

* Perform routine monitoring reviews/audits of Design History Files to assure compliance to the company's procedures

The requirments for the Quality Engineer are

* BS in Science/Engineering or equivalent experience

* Minimum of 3 years' quality/regulatory experience in a high tech manufacturing environment, preferably in a medical device organization/FDA regulated environment

* Minimum of 2 years' managerial experience

* Knowledge in ISO-13485, ISO 14971 GMP, FDA regulations

Our company is an organization that has created a technology that addresses the need for real-time, prognostic data in complex medical and surgical procedures. These complex procedures often involve compromised vasculature, delayed ischemia, or other serious pathophysiology, resulting in high rates of morbidity, delayed recuperation, poor patient outcome and higher overall costs. Our client's patented technology can provide an early warning of impending tissue ischemia, help target appropriate therapies, and rapidly assess the effect of interventions on cerebral blood flow (CBF), thus providing clinicians with a powerful tool to enhance patient care

If you are interest in this position, please contact me at or you can directly apply below. This position included a competitive salary and bonus structure that is comparable with current salary and experience.

Keywords: Michael Page, Waltham , Quality Engineer-Medical Device-Waltham, MA, Other , Waltham, Massachusetts

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