R&D Laboratory Supervisor
Our client a medical device company based in Galway are seeking an R&D Laboratory Supervisor
The person in this role will provide supervision of the R&D Structural Heart Laboratory in Galway, to provide an informative, quality, and efficient testing service to the Structural Heart New Product Development teams. The person will be responsible for ensuring that testing of Finished Devices, Components, Prototype Devices and Non-Conforming devices is carried out in accordance with GMP and GLP. The supervisor shall ensure the laboratory and its users adhere to Corporate and Regulatory requirements in the completion of Design Verification testing, Complaints Investigation, Technical Investigation, test method optimization, test method development and test method transfers.
- Demonstrate a primary commitment to patient safety and product quality.
- Manages day-to-day laboratory activities.
- Ensures that adequate resources (i.e. equipment, staff, consumables, facilities, etc.) are maintained to meet the department and company goals.
- Implements policies and procedures to maintain compliance to standards and quality systems.
- Keeps abreast of Industry best practices for test methodologies and proposes new or alternative test methods where gaps exist in current test capabilities.
- Manages method improvement activities, develops new test methods, and transfers methods into and out of the lab.
- Provides technical oversight and leadership to employees who are responsible for performing laboratory functions.
- Supervises junior engineers and technicians and ensures that they are trained and skilled for their assigned roles in the lab.
- Develops direct reports by assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
- Responsible for controlling access of all persons entering the lab.
- Works closely with product development teams to develop test protocols.
- Manages the scheduling, prioritization and completion of test plans.
- Creates standardised reporting systems to communicate results to customers.
- Ensures the timely review, compilation, interpretation and communication of results.
- Final review and approval of laboratory results, protocols, reports, SOPs, etc.
- Evaluates requests for non-routine and unplanned testing and facilitates these requests as needed.
- Participates in cross functional teams to perform troubleshooting on new products/process problems as related to test method, design, material or process.
- Ensures constant vigilance in the laboratory for non-conforming events and develops a culture of transparency, rapid evaluation and escalation to the appropriate level for such events.
- Leads laboratory investigations.
- Manages the purchase, installation and qualification of test equipment.
- Ensures test equipment is maintained and calibrated to appropriate levels.
- Serves as a representative for the department in all internal / external Audits as functional expert.
- Maintains and enhances cross-functional and cross-site team relationships.
- Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
- Primary Degree in Science or Engineering. Min. FETAC level 8
- Strong new product development/implementation lab experience in the medical device or pharmaceutical industry.
- Excellent interpersonal and communication skills with good leadership abilities.
- Excellent analytical and problem solving skills.
- Candidates should have a proven track record of working in a fast-paced environment with strong technical capabilities
- The ability to describe difficult concepts in simple terms.
- Proficient in statistical analysis methods, particularly Measurement System Analysis (GR&R, capability testing, etc.).
- Experience in medical device test method development and validation.
- Minimum 2-3 years' people management.
- The ability to differentiate between test methods intended for varied purposes (i.e. characterization testing, Design verification testing, in-process monitoring, batch release, etc.) and plan appropriately for their resourcing, development and lifecycle.
I look forward to hearing from you - Bimi Felix, Engineering Recruitment Consultant
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