Director of Regulatory Affairs and Compliance Officer

4 days ago


Gardner, Massachusetts, United States Precision Optics Corporation Inc Full time

Job Summary:

Precision Optics Corporation Inc is seeking a highly experienced Director of Quality Assurance and Regulatory Affairs to join our team. The successful candidate will be responsible for ensuring that our products meet applicable regulatory requirements and quality standards.

About the Role:

The Director of Quality Assurance and Regulatory Affairs will be responsible for all quality assurance and regulatory functions across Precision Optics Corporation's Portland & Gardner sites. This includes ensuring that our QMS and all aspects of quality assurance are compliant with current and future US FDA, ISO, ITAR, and other applicable regulations.

Key Responsibilities:

  • Ensure that Precision Optics Corporation's products meet applicable regulatory requirements and quality standards.
  • Develop and implement 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).
  • Serve as the primary internal subject matter expert on ITAR issues.

Requirements:

  • Candidate must be a US Person, per ITAR definition (a US Citizen, Permanent Resident, or a Protected Individual with Refugee Status)
  • 8 to 10 years of experience in quality assurance & regulatory affairs, preferably in process-oriented manufacturing operations in a 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 3 years of experience in medical devices and FDA QSR, ISO 13485 & EU MDR; defense/aerospace industry experience desired

Salary:

$120,000 - $150,000 per year, depending on experience.



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