Quality Assurance Spv

The Quality Assurance (QA) Manager will be responsible for managing the MycoScience Quality Management systems. The role is responsible for the coordination and implementation of on-site and desk/documentation customer audits of MycoScience and, related observations, Non-Conformances, CAPAs and communication of system results.
Core Competencies and Responsibilities include:

• Act as point of contact between MycoScience, and it's customers on key compliance issues.
• Participate on Quality Management System (QMS) integration team.
• Leading and tracking in Millstone's Mastercontrol electronic QMS as site administrator for MycoScience.
• Leading the internal audit program and compliance with regulatory requirements.
• Leading the CAPA program (CAPA, Complaints) and compliance with regulatory requirements. Maintain oversight on the day to day progress of quality issue records.
• Leading inter-departmental investigations with applicable departments for assessing and addressing potential quality issues.
• Review and approval of equipment and test method validation protocols and reports.
• Responsible for managing the Quality Assurance team.
• Other quality-related tasks as assigned.

• Bachelor's Degree
• 5+ years of relevant experience in Quality, Management, Engineering or Microbiology based testing
• Attention to detail with the ability to recognize and communicate potential issues
• Advanced math skills - basic statistics
• Advanced ability to create Excel, PowerPoint and Word documents
• Ability to write or re-write procedures, forms and master batch records
• Excellent organizational skills with the ability to provide supervision and leadership
• Excellent interpersonal skills
• Knowledge of standards and requirements related to FDA/GMP compliance
• Knowledge of standards and requirements related to ISO 13485 & 17025 compliance
• Knowledge of medical device testing specifically microbiology based testing or medical device manufacturing
• ASQ or RABQSA certification preferred (i.e. CQE, CQA, Lead Auditor)
• ISO 13485 Lead Auditor certification or equivalent preferred
• ISO 17025 Lead Auditor certification or equivalent preferred