Quality Technician (Electronics/Medical Devices)

Brainpower360

Richmond

Sur place

CAD 60 000 - 90 000

Plein temps

Il y a 6 jours
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Résumé du poste

Brainpower360 in Richmond, BC, Canada seeks a skilled QMS Document Control Specialist to manage the full lifecycle of quality documents and ensure strict control of revisions and distribution.

You will uphold ISO 9001/13485 standards, support audit readiness with complete documentation, and implement change requests within our regulated electronics environment.

This role requires 2–3 years in document control, eQMS administration experience, and a degree in engineering or quality assurance.

Qualifications

  • Bachelor’s degree or Diploma in Engineering, Quality Assurance or a related field preferred.
  • 2–3 years of experience in document control within a relevant industry.
  • Experience serving as an eQMS system administrator and supporting audits.

Responsabilités

  • Manage the full lifecycle of QMS documents (SOPs, work instructions, quality manuals, drawings and specifications).
  • Maintain document control processes and ensure eQMS compliance with 21 CFR Part 11 where applicable, GDP, and ISO standards.
  • Support audit readiness by providing required QMS, regulatory, and customer documentation.
  • Implement and track document change requests to align with change management procedures.
  • Control revisions, approvals, and distribution to ensure current versions are accessible.
  • Conduct routine audits of controlled documents and drive process improvements.
  • Support additional duties to uphold quality objectives.

Connaissances

Document control
eQMS administration
ISO 9001 knowledge
Audits experience
Change management

Formation

Bachelor’s degree or Diploma in Engineering, Quality Assurance or related field

Outils

eQMS platform

Description du poste

  • Manages the full lifecycle of QMS documents (e.g., SOPs, work instructions, quality manuals, technical drawings, and specifications), controlling revisions, approvals, and distribution.
  • Ensures all document control processes and the eQMS comply with 21 CFR Part 11 requirements (electronic records/signatures), GDP, and international standards.
  • Leverages deep knowledge of ISO 9001 and ISO 13485 to actively facilitate audit readiness, providing necessary documentation for QMS, regulatory, and customer audits.
  • Implements document change requests to ensure alignment with change management procedures and quality improvements.
  • Controls document revisions, approvals, and distribution processes, ensuring the latest versions are accessible to relevant personnel.
  • Conducts routine audits of controlled documents and records, leading process improvement initiatives for documentation workflows.
  • Performs other duties as assigned to support the overall quality objectives of the organization.
Education:
  • Bachelor’s degree or Diploma in Engineering, Quality Assurance or a related field preferred. Equivalent work experience will be considered
Work Experience:
  • 2 to 3 years of experience in document control within an electronics manufacturing or related industry.
  • Experience serving as a system administrator, superuser, or primary support point of contact for an eQMS platform.
  • Experience supporting audits and maintaining compliance documentation.
  • Experience working in an environment regulated by ISO 9001 and associated standards.
  • Demonstrated experience overseeing or coordinating a corporate Training Program within a regulated environment.
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