Director of Quality Assurance and Regulatory Affairs

Description

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.

Requirements

Training, Skills, Knowledge and/or Experience

• 8 to 10 years of experience in quality assurance & regulatory affairs, in process-oriented manufacturing operations in a Medical Device regulated environment.
•   Minimum 3 years of experience leading quality management within a significant segment of a large manufacturer or the entire operation of a smaller manufacturer.
• Minimum 10 years of experience in medical devices and FDA QSR, ISO 13485; some defense/aerospace industry experience desired.
• Demonstrated experience in implementation and continuous improvement of the QMS and risk management tools to improve quality, reduce costs and improve efficiency.
• Demonstrated organizational and leaderships skills, including establishing, supporting, and sustaining a culture of quality and compliance within an organization.
• Experience with ITAR regulations in technology or electronics industry preferred.
• Lean and/or Six Sigma certification/experience preferred.
• Proficiency with Microsoft 365 apps suite, and project management tools.

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 employees.

Working Conditions

This job operates in manufacturing and engineering laboratory environments including ISO class 8 cleanrooms. PPE required when in controlled environment rooms or cleanrooms.

Physical surroundings

This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets.

Physical Effort

While performing duties of this job, the employee is occasionally required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear

Travel

In-person, Mon to Fri in Littleton, MA; 20 to 25% travel to Gardner, MA and South Portland, ME sites.

Other Requirements:

This position involves access to technology that is subject to U.S. export controls. Any job offer made will be contingent upon the applicant’s capacity to serve in compliance with U.S. export controls