Senior Quality Engineer

Summary:
This position requires an experienced quality professional, who will be responsible for effectively maintaining customer commitment and compliance level established for the ISO9001:2015 Quality Management System, as well as processes consistent with ICH Q7 standards. The candidate must be able to work independently while supporting multiple groups at the Boston and Billerica sites.


Core Duties and Responsibilities:

• Provide support in general quality program issues for assigned product lines to support Quality Management System effectiveness.
• Oversee generation, approval, and compliance management of applicable ISO, ICHQ7, QSR, QMS documentation.
• Audit/create/review/approve/release production Quality System documents/SOPs/work instructions as required.
• Oversee the investigation, implementation and execution of CAPAs, deviations, Out-of-Specification and customer complaints for designated Manufacturing areas.
• Perform/supervise and administer internal quality audit program.
• Provide QA support for customer and certification audits.
• Provide QA support for supplier audits.
• Monitor and administrate handling and tracking of customer complaints.
• Maintain and monitor trending data for ICHQ7 manufacturing operations.
• Generate and present Product Quality Review data.
• Provide support for Continuous Improvement projects as needed.