Quality Assurance Auditor I

Merit Medical Systems, Inc.•South Jordan, UT

1d•Onsite

About The Position

Responsible for auditing medical products to ensure that they have been manufactured according to Merit’s policies, procedures, specifications and standards. Also audits the system by which product is produced.

Requirements

Education and experience equivalent to a high school diploma and a minimum of two years of related work experience with one of the years being in quality assurance/quality control work 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.
Communication and interpersonal skills and the ability to work well with others.
Demonstrates the ability to operate complex test equipment.
Able to perform all Quality Assurance Auditor functions for one of the following areas: Clean Room, Molding, Label Control, IQA

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
Complex testing equipment operation
Work order close-outs/sign-offs
Material testing products/NC tracking, maintenance, labeling
Auditor training
Dimensional inspection
Systems auditing

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 complex testing equipment in verifying that final product meet specification.
Performs dimensional inspections.
Initiates and makes copies of final inspection paperwork.
Performs product transfers as applicable.
Tracks and maintains NC's and material testing products.
Submits materials for MEM/IR testing.
Performs specification training for production employees.
Quarantines product when discrepancies are noted.
Performs work order close-outs.
Performs other related quality auditing tasks, as required.