Quality Technician (Electronics/Medical Devices)

Job summary

Manage the lifecycle, revision control, approval, and distribution of QMS documents, ensuring eQMS and document control processes meet regulatory and quality standards. Support audit readiness, implement document changes, conduct routine document and records audits, and improve documentation workflows.

Job details

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.

What you’ll do

Manage the lifecycle, revision control, approval, and distribution of QMS documents, ensuring eQMS and document control processes meet regulatory and quality standards. Support audit readiness, implement document changes, conduct routine document and records audits, and improve documentation workflows.

Requirements

The role prefers a bachelor’s degree or diploma in engineering, quality assurance, or a related field, while equivalent experience may be considered. Candidates should have 2–3 years of document control experience, eQMS administration or support experience, audit and compliance documentation experience, familiarity with ISO 9001-regulated environments, and experience coordinating a regulated training program.

Listed skills

• Compliance Documentation · Preferred
• Change Management · Preferred
• Process Improvement · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Document Control
• Electronic Quality Management Systems
• 21 CFR Part 11 Compliance
• Good Documentation Practices
• ISO 9001
• ISO 13485
• Audit Readiness
• Change Management
• Quality Management Systems
• Document Revision Control
• Training Program Coordination
• Process Improvement
• Compliance Documentation
• Electronics Manufacturing

Job areas

• Manufacturing
• Engineering
• Healthcare
• Administrative

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