Quality and Regulatory Affairs Specialist - Medical Devices

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POST DATE 8/26/2016
END DATE 12/19/2016

Diedre Moire Corporation, Inc Worcester, MA

Worcester, MA
AJE Ref #
Job Classification
Full Time
Job Type
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Generous compensation package with competitive salary and bonuses, company paid health and wellness benefits. Company matched 401(k), profit sharing, stock options, and pension. Vacation time from start with paid time off for personal days, sick days, and holidays. Upwards mobility and chance to directly impact the success and growth of the organization.

Requires past experience creating, processing, reviewing, filing, validating and otherwise handling:

*** Nonconforming Material Reports (NCMRs) and Rework Orders.

*** Corrective Action Reports (CAR's).

*** Preventive Action Reports (PAR's).

*** Process Change Orders (PCO's).

*** Device History Records (DHR).

*** Mandatory Device Master Records (DMR).

Requires 4+ years of experience in Medical Device Regulatory Affairs for an ISO 13485 environment.

Education Requirements: Bachelor Degree
Minimum Experience Requirements: 2-5 years
Job City Location: Worcester
Job State Location: MA
Job Country Location: USA
Salary Range: $70,000 to $110,000

WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs. Jobs Career Position Hiring.

Top 10 Job Site Top 10 Careers Site QC QA Quality Control Quality Assurance Regulatory Affairs Quality Management System ISO 13485 FDA cGMP Medical Device Audit MRB Materials Review Board 510(k) 510K DHR Device History Record DMR Design Master File Risk Analysis Risk Management Clinical Instrument Clinical Diagnostic Medical Equipment General Medicine Endoscope Camera Penlight

DISCLAIMER: We will make every effort to consider applications for all available positions and shall use one or more of the contact methods and addresses indicated in resume or online application. Indicated location may be proximate or may be desirable point of embarkation for paid or unpaid relocation to another venue. Job descriptions may fit single or multiple presently available or anticipated positions and are NOT an offer of employment or contract implied or otherwise. Described compensation is not definite nor precise and may be estimated and approximate and is negotiable depending on market conditions and candidate availability and other factors and is solely at the discretion of employers. Linguistics used herein may use First Person Singular and First Person Plural grammatical person construction for and with the meaning of Third Person Singular and Third Person Plural references. We reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Response to a specific posting or advertisement may result in consideration for other opportunities and not necessarily the incentive or basis of the response. Nothing herein is or may be considered a promise, guarantee, offer, pledge, agreement, contract, or oath.