Director of Quality Assurance and Regulatory Affairs

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 and Littleton 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

• Ensures that Precision Optics Corporation’s products meet applicable regulatory requirements and quality standards.
• Ensures that POC’s 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 corrective and preventive actions (CAPA).
• Serves as the Management Representative and works closely with cross-functional leaders to manage, develop, and implement Quality initiatives across the organization.
• Ensures alignment of quality objectives, individual and departmental goals with corporate strategic objectives; develops, monitors and reports on quality KPIs and metrics.
• Drives the development and implementation of strategic plans and initiatives to deploy/transform and continuously improve QMS tools, software, and processes to help ensure conformance to established quality and delivery targets.
• Provides QA/RA department leadership and support to all phases of product development & NPI/transfer programs to help meet DFMA, DFT, and DTC goals.
• Develops internal controls, tools, and processes to assure ITAR and EAR compliance and serves as the primary internal subject matter expert on ITAR issues; oversees export compliance activities and responds to BIS inquiries or audits.
• Oversees DSP-5s, TAAs, MLAs and EAR SNAP-R applications and support documentation and AES filings; partners with engineers and program managers to determine jurisdiction and classification of products & technical data.
• Fosters a collaborative and high-performance culture based on Lean and continuous improvement principles; utilizes best practices, technological advancements, and industry benchmarks to enhance quality and productivity.
• Interfaces with key customers during negotiations relating to quality plans, agreements, and regulatory requirements.
• Provides leadership to the QA/RA team; mentors, retains, and develops departmental talent.
• Perform miscellaneous duties and projects as assigned and required.