Quality Team Lead – 1 Year FTC
Aerogen is Ireland’s largest indigenous Med-tech company, we continue to rapidly grow our domestic and global presence and our Purpose and Ambition “to build a truly great global life science company that transforms patient lives through world-leading aerosol drug delivery” has never been stronger.
Aerogen is the world leader in Acute Care Aerosol Drug Delivery recognised through multiple MedTech awards and seven times winner of the Zenith awards for Respiratory Care Excellence in North America. We make a difference to patients’ lives every day, having already reached 14 million patients in over 75 countries.
The Quality Team Lead is responsible for managing the Quality Control Inspection team in the understanding and execution of appropriate inspection processes across Receiving, In Process and Final Inspection. Other activities may be assigned as needed.
Provide mentoring and coaching
- Provide Direct Supervision to Quality Inspectors ensuring that all resources are properly trained and cross trained as required across Receiving, In Process and Final Inspection steps.
- Manage daily work assignments of Quality Inspectors including overseeing employee job performance such as attendance, quality and productivity.
- Plan, assigns and adjusts work priorities to meet daily, weekly, monthly customer sales order requirements.
- Supports Quality reporting metrics; provides data for tracking metrics. Assists in development of root-cause analysis and ensures corrective/ preventive actions are implemented to address non-conformances.
- Initiation and support of continual improvement solutions for new and enhanced methods for inspection, testing, and evaluation of data throughout Aerogen’s processes.
- Work with relevant Engineering Teams to establish inspection plans, frequencies and test methods for incoming material/parts.
- Overall responsibility for GMP standards and compliance within Aerogen’s manufacturing area
- Manage assigned aspects of the quality system in compliance with ISO 13485, FDA QSR, MHLW and Canadian Quality System requirements.
- Quality system training of Aerogen personnel as per defined training plans.
- Perform other assigned tasks and support all aspects of the Quality System as directed by the Manager.
- BE/BS/BA Degree. A Post-graduate qualification in Quality Assurance is preferable although not mandatory.
- At least one to three years Supervisor experience or related role within the medical device industry.
- Ability to work on own initiative and lead a team.
- Strong team member with the ability to identify and drive implementation of innovative quality improvements.
- Ability to consistently meet deadlines.
- Demonstrate and actively promote high levels of professional quality engineering.
- Good communication skills. Must have the ability to communicate effectively at all levels of the company.
- Ability to write clear, concise technical protocols and reports.
- Good administrative/organizational ability with high level of attention to detail.
- Ability to liaise with suppliers, customers and regulatory contacts in an informed professional manner.
- Thorough understanding of ISO 13485 and FDA QSR.
Typical office environments, with work also performed in R&D and manufacturing labs, and customer/supplier locations.
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