Richmond
On-Site
We are seeking a Quality Systems Specialist to join our client, a leading manufacturer in the electronics space located in Richmond, BC. The successful candidate will contribute to and support the transfer of product designs from development into manufacturing, as well as the maintenance and continuous improvement of production processes.
Responsibilities
Manage the full lifecycle of QMS documentation, including SOPs, work instructions, quality manuals, technical drawings, specifications and controlled records.
Administer and support the eQMS, ensuring compliance with 21 CFR Part 11, Good Documentation Practices, ISO 9001, ISO 13485 and applicable regulatory requirements.
Control document revisions, approvals, distribution and change requests, while conducting routine audits and driving documentation and workflow improvements.
Support audit readiness and regulatory compliance by maintaining QMS, regulatory, engineering, NDA and quality records, and providing documentation for internal, customer and regulatory audits.
Oversee the corporate training program, including eQMS training, employee training on document-control processes, and accurate maintenance of training records.
