Senior Supplier Quality Engineer
Job details
Headquartered in the vibrant city of Galway, 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 eight-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 A day in the Life consists of:
- Ensuring that suppliers deliver quality parts, materials, and services.
- Build Strong relationships with suppliers focusing on strong collaboration, communications, and monitoring/planning activities.
- Appropriately train, develop and manage resources within Supplier Quality Team to ensure objectives are communicated and delivered within agreed requirements.
- Supporting Quality Management in the development of key objectives and strategies to ensure continuous growth of personnel and quality systems improvements.
- Manage and led all process validation activities including IQ, OQ and PQ with existing and new Suppliers.
- Ensure effective and timely closure of Quality System documentation (Audit Actions, SCAR’s, SCN’s, PAN’s, etc.).
- Lead Quality Engineering support at Aerogen on project activities i.e.: Design Improvements, Supplier Transfer’s, Cost Improvements, and New Product Introductions etc.
- Work with Manufacturing Quality to establish inspection plans, frequencies, and test methods for incoming material/parts.
- Champion continuous process improvement and, in conjunction with other functions, analyze feedback and identify and implement appropriate problem solving and statistical techniques to improve quality of manufactured product and overall effectiveness and efficiency of processes.
- Overall responsibility for GMP standards and compliance within Aerogen’s Project Teams and Supplier Engagement.
- BE/BS Degree.
- A Post-graduate qualification in Quality Assurance is preferable although not mandatory.
- At least eight years Quality Engineering experience or related role within the medical device/pharmaceutical industry.
- Understanding of ISO 13485 and FDA QSR standards.
- Experience with reviewing and approving process validation activities (IQ, OQ, PQ, TMV etc)
- Ability to work on own initiative.
- Strong team member with the ability to identify and drive implementation of innovative quality improvements.
- Ability to work within project teams, consistently meeting deadlines and ensuring that all actions are being addressed appropriately.
- 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 and with suppliers.
- Good administrative/organizational ability with high level of attention to detail.
- Excellent medical care .
- ‘ Aerogen Connect’ – our employee led programme which supports our global teams to unite and have fun.
- We pledge 1% of p rofits and time to charities and organisations
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