About Aerogen:
Headquartered in the vibrant city of Galway, Ireland, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards and ten-time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to patients’ lives every day, having already reached 20 million patients in over 80 countries.
Our talented and skilled team collaborate to innovate, challenge and test not only in relation to our products but every facet of how we work. We lead the way, finding innovative solutions to even the most complex problems, all in the name of delivering better patient care.
Our business is growing rapidly across the globe and as we grow, our core culture of “We Care” universally connects us. We believe that your ambition and integrity fuels ours and we are committed to supporting our employees to reach their full potential through tangible investment in their careers. Join us as we continue to #discoverbetter.
What is the role?
Quality Engineer II is responsible for quality engineering activities for manufacturing processes, materials, and products as well as within Project Teams. Other activities may be assigned as needed.
What are the key responsibilities?
* Quality Engineering support at Aerogen manufacturing process including investigation of root cause analysis of quality issues in manufacturing and managing quality related nonconformance, corrective action and preventive action in addition to addressing ongoing compliance.
* Appropriately train, develop and lead relevant resources in Quality Assurance team to ensure objectives are communicated and delivered within agreed requirements.
* Provide direct supervision to Quality Inspectors ensuring that all resources are properly trained and cross-trained as required across the inspection steps at incoming, in-process, final and shipping release. Manage work assignments of Quality Inspectors to achieve business objectives, including overseeing employee job performance such as attendance, quality and productivity.
* Ensure sufficient handover meetings are implemented between Production Shifts with all activities and metrics clearly outlined and closed.
* Support validation activities within production environment inclusive of IQ, OQ and PQ.
* 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, EU MDR, 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.
What education and experience are required?
* BE/BS Degree. A Post-graduate qualification in Quality Assurance is preferable although not mandatory.
* At least 3 years Quality Engineering experience or related role within the medical device industry.
What key skills will make you great at the role?
* Technical Writing – Ability to produce clear, concise, and well-structured technical protocols and reports.
* Data analysis: Experience in using statistical methods and problem solving tools
* Collaboration: Effective communication and interpersonal skills; written, verbal and presentation.
* Planning and Organisation: Good organizational, and project management and skills with meticulous attention to detail and a sense of urgency.
* Demonstrate and actively promote high levels of professional quality engineering
* Thorough understanding of ISO 13485, EU MDR and FDA QSR.
* Ability to work on own initiative.
What is it like to work at Aerogen?
Our purpose is to transform patient lives and our ethos is to #discoverbetter. This also translates to how we look after our people. We want talented, passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non-financial rewards and benefits. There’s something for everyone! Here is an idea of what we offer:
* Excellent medical care.
* Bonus & Pension.
* Long-Term Incentive Plan.
* ‘Aerogen Connect’ – our employee led programme which supports our global teams to unite and have fun.
* We pledge 1% of profits and time to charities and organisations.
Aerogen is committed to promoting diversity, inclusion and equality in the workplace. If you have any difficulty using our application process, please contact us by emailing careers@aerogen.com. Please include your name and preferred method of contact.
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