Quality Lab Leader - Electro-mechanical Devices

Quality Lab Leader - Electro-mechanical Devices: South Dublin.

In this role you will be responsible for final batch release and complaints processes for commercial product, including the management of any associated outsourced activities.

Responsibilities include the start up and implementation of the Quality laboratory and the qualification of lab equipment, processes, and/or test methods related to product release and complaints testing. Activities include, but are not limited to, identification of product defects and potential issues, data analysis, and trending. This position also supports the continuous improvement of testing and/or quality assurance process, provides technical support on equipment and methods, and is responsible for proactively managing complex issues with a high level of autonomy.

As the Quality Lab Leader you will set priorities for the Quality lab and be accountable for the success of all deliverables, while ensuring related operations follow applicable corporate policies and procedures, as well as applicable regulations and standards.

General Lab Responsibilities:
• Identifies and evaluates new and/or equipment improvements.
• Responsible for purchasing, installation and validation of equipment.
• Serves as technical expert regarding general laboratory instrumentation, equipment, and processes.
• Manages and maintains on-time calibration and preventive maintenance of laboratory equipment.
• Communicates with suppliers to drive on-time completion of activities.
• Coordinates repairs and remediation activities, as needed.
• Drives investigation activities for out of specification (OOS) calibration results.
• Supports test method and fixture development, as needed.
• Maintains laboratory safety and organisation as well as operational and functional conditions.
• Manages inventory and related documentation including, but not limited to, laboratory supplies, test samples, and chemicals.
• Identifies and implements continuous process improvements in the laboratories, as well as contributing to lab network initiatives.
• Leads or contributes to root cause investigations and corrective / preventive actions, as needed.
• Identifies and supports qualifications of new lab suppliers, when needed.
• Supports Supplier Quality team with maintenance activities for existing suppliers.
• Ability to work effectively in project teams, as needed.
• Assists with failure or non-conformance investigations.
• Supports audits (regulatory, customer, internal) as a subject matter expert.
• Performs internal audits and compliance assessments, when needed.
• Leads change management activities for lab processes.
• Supervises technicians performing complaints and/or release activities.
• Conducts on-boarding and ongoing training program of lab associates.
• Maintains good laboratory practices (GLP) consistent with corporate and regulatory guidelines.
• Maintains good documentation practices (GDP) when generating test data and records in accordance with ISO, cGMP and other applicable regulations and standards.

Complaints management:
• Manages and drives completion of commercial product complaints activities: planning, sample management, investigations, reporting, oversight of activities performed by support team(s) and/or supplier(s)
• Performs complaint Quality Data Analysis, as needed. Identifies and reports trends and/or triggers for significant complaint issues

Product Release:
• Performs final product release operations. Maintains documentation, reviews inspection results, and dispositions product.
• Initiates or performs non-conformance investigations, if needed.
• Trends incoming inspection data, as needed.
• Identifies and reports trends and/or triggers for initiating supplier complaints.

Interested applicants should have:
• Bachelor degree in Engineering, Science, or other related discipline.
• At least 5 years’ experience in a similar role is required, or equivalent: Pharmaceutical, medical device, diagnostics, or Quality Control.
• Knowledge of the operation of mechanical measurement and testing equipment  and CT scanners
• Understanding of industry standards and regulations such as ISO, FDA, OSHA, ASTM
• Excellent written and oral communication skills
• Superior attention to detail
• General knowledge of problem-solving and root cause analysis methodology
• General knowledge of statistical techniques
• Ability to handle multiple tasks/projects simultaneously under general supervision
• Ability to work with diverse, multi-national, cross-functional teams

The below skillset is an advantage (not essential):
• Education or experience related to electromechanics and/or electromechanical devices.
• Ability to troubleshoot electromechanical devices and software
• Experience with equipment qualification
• Experience with computer system validation