The QA Manager – Operations will be responsible for the Non-Conformances, QA Review/Release functions, Post Sterilization Release and the Laboratory. The Quality Assurance Manager will be responsible for interfacing with internal and external stakeholders, including Millstone clients and suppliers.
Core Competencies include:
· Lead quality issues and partner with Internal Customers; Lead effective containment and
corrections/corrective actions
· Lead Millstone’s non-conforming product program (NONCs) and compliance with regulatory
requirements.
· Lead Millstone’s QA Review/Release and Post Sterilization Release process
· Lead the Material Review Board and manage the scheduling of non-conforming product
dispositioned as repack.
· Responsible for Laboratory functions including bubble emission testing and water testing
· Lead inter-departmental investigations with Operations, Engineering and Quality groups for
assessing and addressing potential quality issues.
· Other quality-related tasks as assigned.
· Participate in internal or external audits as necessary
· Support client program quality activities including complaint investigation, change
management and client audits as necessary
· Participates in new program launch process