12 Oct
|
Brainpower360
|
Richmond
12 Oct
Brainpower360
Richmond
- 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 setting.
📌 Quality Technician (Electronics/Medical Devices) (Richmond)
🏢 Brainpower360
📍 Richmond