Medical Device QA Auditor: Evening Shift & Growth

Merit Medical Systems, Inc.

South Jordan (UT)

On-site

USD 42,000 - 62,000

Full time

9 days ago
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Benefits offered by this job

Multiple shifts
Medical/Dental & Other Insurances
Low Cost Onsite Medical Clinic
Onsite Cafeterias
Vacation & Holidays
401K

Job summary

Merit Medical Systems, Inc. in Utah is seeking a dedicated quality auditor to verify that medical products are manufactured in accordance with Merit's policies, procedures, specifications and standards.

You will generate and distribute NC's, audit production processes to confirm Device History Records are complete, inspect finished products, and complete final inspection paperwork, in alignment with GMP/QSR requirements.

Qualifications

  • High School Diploma with at least 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.

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.

Skills

Attention to detail
Computer skills
Communication
Operate basic test equipment

Education

High School Diploma
1 year related experience

Tools

Basic test equipment

Job description

Merit Medical Systems, Inc. in Utah is seeking a dedicated quality auditor to verify that medical products are manufactured in accordance with Merit's policies, procedures, specifications and standards.

You will generate and distribute NC's, audit production processes to confirm Device History Records are complete, inspect finished products, and complete final inspection paperwork, in alignment with GMP/QSR requirements.

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