256H - Quality Assurance Auditor I (Hourly)

Merit Medical Systems, Inc.•Richmond, VA

28d•Onsite

About The Position

This position is responsible for auditing medical products to ensure that they have been manufactured according to Merit’s policies, procedures, specifications and standards. Merit Medical is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit has made it a priority to understand customers, innovate, and deliver life-changing products and services.

Requirements

High School Diploma with a minimum of one year of related experience.
Demonstrated knowledge of business mathematics.
Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs
Excellent attention to detail and the ability to meet deadlines in a timely manner.
Ability to learn to operate basic test equipment.
Communication and interpersonal skills and the ability to work well with others.

Nice To Haves

Production process auditing for specific and general area -- PPS’s, QAP’s, MPS’s, and GPS’s
Finished product auditing
Basic test equipment operation.
Final inspection paperwork
Work order reviews
Product final inspection
Generation and distribution of NC’s
Specification training

Responsibilities

Generation and distribution of NC’s for specific area -- QAP’s and MPS’s.
Audits the production process to confirm that Device History Records are completed according to Device Master Record/QSR/GMP regulations.
Audits finished products to ensure that it conforms with Device History Records/applicable specification and procedures.
Completes final inspection paperwork.
Performs work order reviews for ECN's, EPWO's, NC's, etc.
Documents inspections/rejections on inspection paperwork.
Segregates product when discrepancies are noted.
Initiates and ensures closure of NC’s.
Accountable for the disposition agreement/verification of NC’s.
Initiates, identifies (labels) and ensures closure of NC’s. Enters information into NC database.
Operates basic testing equipment in verifying that final product meet specification.
Performs other related quality auditing tasks, as required.