Quality Compliance Specialist

Position Summary

The Quality Compliance Specialist provides Quality Assurance support and helps administer the CAPA program and the internal and external audit programs. The Quality Compliance Specialist will assist with ensuring regulatory compliance for the company, including writing and revising relevant SOPs/WIDs and constructively implementing mechanisms for new regulations, standards, and/or regulatory guidance. They will assist with Quality System Planning and maintaining and collect Quality Management System (QMS) data, including periodic Management Reviews, quarterly reports, and generating system metrics. This position could also be tasked to support other aspects of the Quality Management System to assist with compliance organizational needs.

Other key skills required:

• Candidates will possess independent work habits, strong organizational skills, enhanced attention to detail, and diplomacy.
• This position requires strong computer skills as well as ability to compile, analyze, and sort data to identify trends/failure modes.
• Extensive written and verbal communication skills required including investigation, writing, reporting skills are strongly recommended.
• Ability to scan for new or revised applicable regulatory regulations, standards, and guidelines; review and analyze new requirements, provide periodic updates to select groups.
• Support BFDf quality, design control practices, and risk management activities to ensure regulatory adherence.

• May be required to obtain and maintain a DoD Personnel Security Clearance.

   

Education:

• Degree in scientific, technical writing, or public health is preferred

   

Experience:

• 3+ years of Quality System experience (e.g., ISO 9000 or ISO 13485 Quality System) including experience in audit activities preferred;
• Lead Auditor certification preferred but not required