Compliance Engineer

at  Hanley Calibration

Title: Compliance Engineer
This position is based at our clients’ site in the County Waterford area, the purpose of this position is to ensure all department compliance metrics are up to date and the department is always in an audit ready state regarding quality / EHS systems.

WHAT WE NEED FROM YOU IS:

• Third level Qualification in Engineering or equivalent or preferred Level 7 Qualification in Engineering
• Worked previously in a pharmaceutical/Medical Devices manufacturing environment.
• Worked as an Engineering compliance engineer
• Required knowledge to be effective in the role

EXPERIENCE:

5 years in a similar role as the role requires reasonable experience to carry out all tasks as per the role responsibility

SKILLS/BACKGROUND:

Green Belt.
Working knowledge of DMAIC or similar process that drive problem resolution and improvemen

• Track and monitor all department compliance metrics (EHS / Quality)
• Interact with the responsible persons regarding completing action’s related to metrics closure (Carisma, CAPA, DE, MC etc)
• Be the department Quality System MERP’s SME
• Ensuring all monthly forums take place and minuted (EHS / Quality)
• Coordinate monthly Level 1 audits / annual level 2 audits / coordinate interim L3 & L4 audits for department
• Coordinate monthly GEMBA;s with Quality / EHS / Dept SME
• Coordinate Depatment Risk Map and track Risk Assessments to schedule
• Track RMS acions to closure
• Review EHS and Quality alerts with dept SME team and carry out gap analysis
• Ensure all AVL’s are in place, in use and up to date
• Complete any department related DE’s raised with department SME’s
• Complete any department related IN’s with support from the department SME.
• Support organising training courses coming due
• Coordinate all due Dept Documentation with dept admin and approvals
• Manage completion of EHS related metrics
• Arrange monthly EHS inspections
• Arrange and chair monthly EHS meetings
• Prepare the department risk map and coordinate the risk assessment schedule
• Read and understand Standard Operation Procedures applicable to role
• Feed into Tool Box Talks relating to compliance
• Ensure that any training SOP’s are read and CAQ’s signed off on promptly
• Ensure all Safety Permits are filled out as required for each job being carried out
• The maintenance department is audit ready