Job description

Reports to: Quality Manager

Location: St Cloud, MN

Department: Quality - St Cloud Campus

FLSA Classification: Exempt

Hours: 8 am - 5 pm primarily

Position Purpose:
The QMS Engineer is responsible for supporting the implementation, continuous improvement, and internal auditing of the Quality Management Systems which govern the processes of medical device manufacturing in our laboratory. The QMS Engineer will also assist in the training of management and associates in QMS best practices for ISO 13485. Manage the internal audit program and report findings to the Quality Manager of the St Cloud Campus.

The primary focus of this position is to monitor, maintain, and update the QMS system and ensure compliance to ISO 13485/21 CFR 820 FDA and EssilorLuxottica Quality policies and procedures. Duties in this position are usually very repetitive, requiring reviewing process and procedure documents and updating them as applicable. The position will require the ability to work independently as well as across multiple departments.

Primary Responsibilities:
Audit and report the progress of the level of implementation of, and perpetual conformity to, the Quality System Requirements in a regulated industry.

Produce documented evidence of conformity/nonconformity to the Group Quality System, ISO 13485:2016, FDA 21 CFR 820 and other relative system standards, at the laboratory level.

Plan and execute follow-up QMS audits and report findings to the Quality Manager.

Actively promote the culture of Compliance to ISO 13485, 21 CFR 820 and EssilorLuxottica Quality Initiatives and Quality Management Systems.

Establish methods of communicating the overall status of the continuous development and improvement of the Quality Management System.

Attend on-going professional development in the field of Quality Management.

Complete reports and other administrative duties in an accurate and timely manner.

Represent the organization’s Quality Directives in line with core values.

Education and Qualifications

Minimum B.A./B.S. degree in a technical discipline required.

Professional certifications as an internal auditor, lead auditor, quality engineer, etc. preferred.

Minimum 5 years of industrial operations experience in a quality management system environment, preferably the medical device, pharmaceutical or biologics industries.

Professional audit planning and report writing experience preferred.

Knowledge and expertise in the ISO/FDA cGMP and QSR, particularly with ISO 13485, ISO 9001, FDA 21 CFR 820.

Demonstrated computer skills (MS Office, general PC navigation, and analytical software tools).

Ability to lead initiatives through influence in a matrixed organization.

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