Quality Assurance Specialist

Job Purpose:

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 positions 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 document control process. Documents managed include but are not limited to release procedures, drawings, and engineering documents, incident/complaint documents.

Duties:

• Write, edit, and review Standard Operating Procedures and various Quality related technical documents (protocols, specification, work instructions, batch records, etc.) in a highly collaborative environment.
• 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

Skills/Qualifications:

• Bachelor's degree and a minimum of 3 years industry experience.
• Knowledge of ISO 13485 and 21 CFR 820.
• Exceptional communication (verbal and written) and interpersonal skills.
• Must be detail oriented with excellent analytical and problem solving skills.
• Proficiency with MS Word, PowerPoint, Excel, Access, etc.
• Positive attitude, honesty and a team player mentality.

Willingness and ability to take on additional tasks and projects as assigned.