Cipher Surgical, Inc., a medical device company located in Chantilly, Virginia, is actively seeking a Quality Assurance Specialist to support the Quality Assurance process and Quality System including Document Control and Records.

Job Duties and Responsibilities:

• Ensure compliance with Cipher Quality Management System (QMS) and applicable regulatory standards (e.g., ISO 13485, 21 CFR Part 820, EU MDR).
• Participate in quality review and release of production lots, ensuring that all batch records, inspections, and testing documentation are complete and accurate.
• Support investigations into nonconformances, deviations, and customer complaints; assist in root cause analysis and development of corrective/preventive actions (CAPA).
• Assist in the execution of internal audits, supplier audits, and regulatory inspections.
• Maintain and revise quality documentation including SOPs, forms, specifications, and work instructions through the document control system.
• Collaborate with cross-functional teams (e.g., Manufacturing, Engineering, Regulatory, Supply Chain) to resolve quality issues and drive continuous improvement.
• Track and trend quality metrics to monitor process effectiveness and product quality.
• Support supplier qualification, monitoring, and incoming inspection activities.
• Assist in employee training and compliance tracking related to the quality system.
• Other duties as assigned.

KNOWLEDGE, SKILLS AND ABILITIES:

• Familiarity with FDA QSR, ISO 13485, and/or EU MDR requirements.
• Experience working in a small to mid-size company with dynamic quality system needs.
• Strong attention to detail and documentation skills.
• Experience working with file and system maintenance procedures.
• Experience working with computer desktop packages such as Microsoft Word, excel, etc.
  Education and Training: Bachelor’s degree in science, engineering or related technical discipline or equivalent combination of education and experience.
  Experience: 5+ years of experience in a regulated industry (i.e. medical device, pharmaceutical, biotech, diagnostics).
  Cipher Surgical, Inc. is an Equal Opportunity Employer
  Job Types: Full-time, Permanent
  Pay: $27.00 - $29.00 per hour
  Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Work Location: In perso

• Ensure compliance with Cipher Quality Management System (QMS) and applicable regulatory standards (e.g., ISO 13485, 21 CFR Part 820, EU MDR).
• Participate in quality review and release of production lots, ensuring that all batch records, inspections, and testing documentation are complete and accurate.
• Support investigations into nonconformances, deviations, and customer complaints; assist in root cause analysis and development of corrective/preventive actions (CAPA).
• Assist in the execution of internal audits, supplier audits, and regulatory inspections.
• Maintain and revise quality documentation including SOPs, forms, specifications, and work instructions through the document control system.
• Collaborate with cross-functional teams (e.g., Manufacturing, Engineering, Regulatory, Supply Chain) to resolve quality issues and drive continuous improvement.
• Track and trend quality metrics to monitor process effectiveness and product quality.
• Support supplier qualification, monitoring, and incoming inspection activities.
• Assist in employee training and compliance tracking related to the quality system.
• Other duties as assigned