Quality Management System Eng.

at  Ormco

Mexicali, B.C., Mexico -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate25 Oct, 2024Not Specified30 Jul, 2024N/AMicrosoft OfficeNoNo
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Description:

JOB DESCRIPTION:

Responsible for maintaining the company’s quality management system.

  • Coordinates the updating and maintenance of procedures and other quality system documents.
  • Performs the issuance and distribution of procedures, work instructions, forms, visual aids and other quality system documents.
  • Manages the quality system training system.
  • Maintains quality system records; such as: TR’s, MRDR’s, complaints, CAPA’s, GMP’s, variances, audit reports and certificates from BSI, FDA, COFEPRIS, etc.
  • Collaborates in the preparation and coordination of the internal audit program of the quality system.
  • Participates in external audits of the quality management system: ISO 13485, GMP, COFEPRIS, FDA and other regulations.
  • Performs internal quality system audits and patrols on good manufacturing practices for medical devices.
  • Prepare the monthly report of QA KPIs, GMPs and MRDRs.

JOB REQUIREMENTS:

  • Industrial Engineer, LAE or similar.
  • Basic knowledge of reading plans and measuring instruments.
  • Knowledge of the ISO 13485 standard is desirable.
  • Preferably have had experience in a similar position.
  • Desirable English language and good writing.
  • Knowledge of using Microsoft Office.

Responsibilities:

  • Coordinates the updating and maintenance of procedures and other quality system documents.
  • Performs the issuance and distribution of procedures, work instructions, forms, visual aids and other quality system documents.
  • Manages the quality system training system.
  • Maintains quality system records; such as: TR’s, MRDR’s, complaints, CAPA’s, GMP’s, variances, audit reports and certificates from BSI, FDA, COFEPRIS, etc.
  • Collaborates in the preparation and coordination of the internal audit program of the quality system.
  • Participates in external audits of the quality management system: ISO 13485, GMP, COFEPRIS, FDA and other regulations.
  • Performs internal quality system audits and patrols on good manufacturing practices for medical devices.
  • Prepare the monthly report of QA KPIs, GMPs and MRDRs

REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Human Resources/HR

Production / Maintenance / Quality

HR

Trade Certificate

Maintains quality system records; such as: tr's mrdr's complaints capa's gmp's variances audit reports and certificates from bsi fda cofepris etc.

Proficient

1

Mexicali, B.C., Mexico