Engineering Compliance Manager

The Engineering Compliance Manager will lead, manage and coordinate Quality related cGMP Engineering practices as aligned with our Quality Management System (QMS).

Requirements

• Ensure Engineering QMS maintenance, in compliance with internal procedures and regulatory standards.
• Manage Engineering Quality compliance activities (Deviations, Change Controls, CAPA, RCA), ensuring timely execution of investigations, CAPAs, providing and gathering stakeholder input to support ongoing activities.
• Monthly reporting of quality performance metrics and planning of any corrective/preventative improvement opportunities.
• Carry out departmental periodic reviews and support document reviews, amendments, and creation.
• Support the Engineering coordinator in the maintenance of the Maximo Asset Management system.
• Working with the Engineering Manager to support timely closure of unplanned maintenance requests.
• Support the operation and maintenance of the SCADA system.
• Lead initiatives in operational excellence to improve product quality and process efficiency
• Collaborate with cross-functional teams to implement best practices and innovations in quality management.
• Responsible for Engineering cGMP Regulatory and EHS audit preparation and hosting.

Benefits

• Competitive compensation & benefit packages
• Challenging opportunities
• A culture of working together in a supportive way built on our strong foundation of values