Quality System Administrator

Medical Metrics Inc•Houston, TX

About The Position

This position will support an ISO 9001 and ISO 13485 compliant Quality Management System, driving compliance with QMS processes and continual improvement actions. Will oversee day to day activities of the QMS in fulfillment of company directives, policies and ISO standard requirements.

Requirements

Four-year undergraduate degree (BA or BS) and/or combination of education and work experience in a Quality or regulated environment of over 4 years.
ISO 9001, ISO 13485, GMP/GLP/GCP or other Regulatory or Quality Systems awareness.
Experience with conducting internal audits.
Strong interpersonal skills
Excellent verbal and written communication skills
Excellent work ethic and attention to detail
Effective time management and organizational skills
Development of training materials and company documents (e.g., procedures, work instructions, etc.)
Knowledge of Microsoft business applications (incl. Word, PowerPoint, Excel, Visio, etc.)

Nice To Haves

Familiarity with electronic Quality Management System platforms

Responsibilities

Manage the Quality Management System document control process for efficient and controlled access to current approved documents.
Track and coordinate documentation change requests from approval through implementation.
Assist with maintaining quality documentation such as training records, SOPs, audit files, and validation documentation, including reviewing, scanning, filing, and indexing.
Monitor and track training of MMI employees to ensure compliance with the training process.
Prepare, create, or update reports and documents as requested, with input from process owners.
Train MMI employees on MMI Quality System procedures.
Assist in developing training materials such as PowerPoint presentations and quizzes for company-wide procedures and processes to document training effectiveness.
Assist in tracking quality management system metrics to support the company’s Quality Objectives.
Assist in maintaining the MMI corrective and preventive action systems and support MMI personnel in developing appropriate corrective actions for observed gaps or non-conformances.
Assist in scheduling, facilitating, preparing, and documenting Management Reviews.
Participate in the internal audit program, including developing the internal audit schedule, preparing and conducting internal audits, summarizing audit findings, and reporting into MMI’s corrective/preventive action program and at Management Reviews.
Coordinate and host sponsor, regulatory, and registrar audits, and assist with MMI audit responses.
Support the Director of Regulatory and Quality Affairs with quality-related tasks and objectives.
Understand MMI’s Quality Policy and support the achievement of quality objectives.
Comply with MMI’s policies and procedures, as well as ISO 9001:2015 relative to job tasks.