• Directly responsible for ensuring documents submitted to Quality are compliant to company procedures, regulatory requirements, and the quality manual.
• Performs project review and audit of Device History Files (DHF’s) and technical files including:
  • Stability protocols and reports
  • Summary of Safety and Performance reports
  • Risk Management plans, reports, FMEAs
  • Post-Market Surveillance plans and reports
  • Performance evaluation plans and reports including scientific, clinical, and analytical documents.
  • Product composition reports
  • Sensitivity and specificity/Repeatability and reproducibility reports
  • Specification reports
  • General Safety and Performance Requirement reports
  • Etc.
• Performs review of data and records supporting the DHF while assessing for good documentation and record keeping practices ensuring appropriate requirements are met.
• Obtains information for clarification from process owners while providing appropriate and relevant feedback.
• Coordinates files upon completion of review for upload into EDMS as necessary.
• Electronically signs as technical approver for quality on applicable documents and within the validated electronic databases.
• Write, revise and/or review Standard Operating Procedures.
• Maintain extensive knowledge of Standard Operating Procedures and policies.
• Supports internal and external audits as required.
• Understands, supports, and communicates Company mission, vision, and values.
• Understands and follows the requirements of the quality system.
• Maintains current training requirements.
• Trains other staff members as requested.
• Adhere to regulatory requirements (including cGMP), standards, procedures, and company policies.
• Recommends, provides, or initiates solutions by actively providing suggestions for improvement.
• Must be willing and able to work on weekends or extended hours as needed.
• Follows regulatory and standard requirements as applicable to the site, i.e. MDSAP, ISO 13485, IVDD/IVDR, and compliance to the site Quality Manual.
• Review and approve quality documentation and records.
• Collaborates and coordinates with internal stakeholders to identify, escalate, and resolve quality issues.
• Other duties as assigned or required.

BEOCS