Summary of Essential Duties and Responsibilities

As directed, the Quality Assurance Specialist is accountable for the continued development, implementation, and improvement of the Quality Systems. This position actively participates in quality guidance, product resolution decisions and statistical problem-solving techniques to Operations Management and Product Development teams for process improvement and continuous improvement activities. This position assists departmental management through the collection, analysis and reporting of organizational quality metrics.

This position is responsible for the development and maintenance of the REVA Medical document control process. Documents managed include but are not limited to release procedures, blueprints, drawings, and engineering documents, incident/complaint documents.

Duties:

• Create and review documents used in good manufacturing practices; monitor audits of production and quality control areas.
• Manage document control and provide oversight of related quality systems such as training and other electronic quality systems to ensure effectiveness.
• Coordinate non-conformance, corrective action preventive actions and deviation processes.
• Conduct Quality investigations (Nonconformance / failure, deviation, CAPA, etc.) and document in appropriate reporting methods and systems.
• Participate in External Quality System / cGMP audits.
• Conduct internal and supplier quality assurance audits in accordance with published audit plans.
• Provide feedback and guidance to staff concerning quality assurance audit results in a manner that is not biased or defensive.
• Identify and analyze quality assurance trends and refer any realized issues to the departmental and executive management. Compile information required for presentation at Management Reviews.
• Implement publishing processes across multiple complex regulatory documents;
• Perform document quality control checks for others in the department, promptly communicating irregularities in documents and coordinating issue resolution.
• Suggest process improvements based on quality assurance audit findings

• Other duties as assigned

Education and/or Experience

Bachelor degree in technical field or equivalent experience.

Minimum of three years related experience in a QSR/ISO, medical device, or similarly regulated environment. Interventional cardiology products manufacturing experience preferred.

Experience and detailed understanding of document control, quality control and inspection activities and requirements.

Sound understanding/familiarity with ISO 13485, 21CFR280, quality system regulation medical device requirements, labor codes and good safety practices.

Required Knowledge/Skills

Good written and oral communication skills, with the proven ability to generate routine reports, procedures, and correspondence.

Experienced with Microsoft Office Suite, Word, Excel, PowerPoint, etc.

Ability to work in a team environment

Experience with common mechanical and facility related systems and tooling/equipment.

Physical Demands/Working Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to sit for prolonged periods of time. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and color vision. The employee is regularly required to perform computer entry and routine mechanical operations.