Job Description
Description:
Overview
The Director of Quality Assurance and Regulatory Affairs (QA/RA) is responsible for ensuring that Precision Optics Corporation’s products meet applicable regulatory requirements and quality standards. Responsible for all quality assurance and regulatory functions across POC’s Portland & Gardner sites. Ensures that the QMS and all aspects of quality assurance are compliant with current and future US FDA, ISO, ITAR, and other applicable regulations. Develops and implements quality and regulatory strategies, policies, programs, and procedures, including internal & external audits, inspections, process verification & validation, supplier performance management, customer complaint management, organizational training needs, and CAPA. Serves as the primary internal subject matter expert on ITAR issues.
Principal Responsibilities
Education Requirements
Bachelor’s degree in engineering, or a related technical/science field. Master's degree preferred
Competencies
In-depth understanding of quality assurance and engineering and related tools, FDA QSR, EU MDR, MDSAP and ISO standards relating to regulation of Medical Devices.
Strong attention to detail, with excellent analytical, problem-solving, and project management skills.
Strong data collection & analysis, problem solving, presentation and communication skills.
Excellent leadership and people skills, with the ability to identify/develop talent, and inspire others to achieve.
Change management and process improvement skills to simplify quality/business processes, tools, and workflows.
Stays current with changing regulations and requirements impacting export compliance activities.
Supervisory Responsibility
Directly responsible for supervising exempt and non-exempt QA/RA, office/administrative, and professional employees
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