Position Title: Quality Assurance Auditor (Medical Devices)

Position Summary

Monitors and reports results of the Quality Management System compliance of the company and in providing guidance for the organization team on matters relating to compliance. As a quality auditor this position performs periodic documented examination and verification of activities, records and processes of quality system from all the regulatory bodies associated with the company, in order to determine the effectiveness and dependability of such system. As an auditor he/she monitors all quality standards for the manufacturing activities and support activities.

Key Accountablities:

• Maintains, and revises policies and procedures for the general operation of the Quality Management Systems compliance program and its related activities to prevent non-conformances.
• Manages day-to-day operation of the program including internal and external audits.
• Collaborates with other departments (e.g., Research and Development, Manufacturing, Operations, Purchasing, Quality, etc.) to direct compliance issues to appropriate existing channels for investigation and resolution. Consults with other members of the team as needed to resolve difficult compliance issues.
• Acts as an independent review and evaluation body to ensure that compliance Issues/concerns within the organization are being appropriately evaluated, investigated and resolved.
• Monitors, and as necessary, coordinates compliance activities of other departments to remain abreast of the status of all compliance activities and to identify trends.
• Identifies potential areas of compliance vulnerability and risk; propose the necessary corrective action plans for resolution of problematic issues, and provides general guidance on how to avoid or deal with similar situations in the future.
• Monitors the performance of the Quality Management System compliance program and related activities on a continuing basis, taking appropriate steps to improve its effectiveness.
• Maintains training to current regulations used to perform internal and supplier quality system audits.
• Other duties as assigned.

Minimum Skills and Capabilities:

• Excellent Written and Verbal Communication
• Understanding of quality system regulations (ISO13485, 21CFR820) and any other international regulations, as applicable
• Ability to interact with all levels within organization
• Analytical skills for compiling and analyzing data
• Computer and software skills
• Ability to motivate others and improve efficiency

Minimum Knowledge & Experience required for the position:

• Bachelor’s degree in a technical discipline, or equivalent experience
• At least a minimum of 2 years’ experience in medical device quality assurance and/or regulatory affairs roles.

No sponsorship visa (H1-B, etc) candidates at this time, sorry.


Qualified candidates must submit their resume in Microsoft Word format along with at least three professional references to:


COYOTE TECHNICAL & EXECUTIVE SOURCING
Phil Montoya
Director of Sourcing