Quality Technician (Electronics/Medical Devices)

• 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.