Medical Regulatory Compliance Engineer

Microboard Processing Inc, a premier EMS firm located in Seymour CT, is experiencing sustained growth and is looking for a key member of our Quality Management team.? This is unique opportunity for the right individual to help make a real contribution to advance our organization to the next level.

Essential Duties and Responsibilities

?Provide experienced direction/assistance in developing/implementing additional processes, procedures and controls in an existing ISO9001 electronics manufacturing environment in order to comply with ISO, FDA, and other applicable regulatory requirements for manufacture of Medical Devices.

?This position is responsible for building upon our quality system from present (ISO9001) to the future (ISO13485 & FDA 21CFR820) medical device growth:

?Modify existing ISO procedures to meet GMP and regulatory requirements

?Develop and implement validation programs, documentation, and reports (IQ,OQ, PQ) in compliance with all relevant QSR?s

?Perform internal audits to ensure the Quality System meets the requirements established by ISO13485, FDA, QSR?s, etc.

?Understand the requirements of the Device History File and be capable of performing all activities associated with DHF maintenance

?Create and utilizes relational databases to collect, analyze, and develop data for measuring compliance with the Quality System requirements for the manufacture of medical electronics

?Work with the Training Department to develop systems and training compliant with FDA requirements

?Drive corrective action and continuous improvement

?Make recommendations for procedure revisions necessary to meet medical device regulatory requirements and GMP?s

?Interfaces with customers and suppliers.? Resolves any Quality related issues, etc.

?The above duties may be supplemented occasionally with other job duties and/or assignments related to objectives.

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?EDUCATION and/or EXPERIENCE

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Requirements:

?Bachelor's degree from an accredited college or university. Five years minimum experience directly related to the implementation and maintenance of an ISO13485 Quality System, in a medical electronics environment.Proficient in the use of? computer software applications (e-mail, Word, Excel and PowerPoint) as well as quality database applications. Possess excellent verbal and written communication skills as well as interpersonal skills.To execute this job successfully, an individual must be able to perform each essential duty satisfactorily.

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All offers of employment are contingent upon successfully passing a drug screen and upon completion of a confidentiality agreement.? Microboard Processing Inc is an Equal Opportunity Employer/Affirmative Action employer.?

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