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Supplier Quality Engineer II
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 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.
What is the role?
The Supplier Quality Engineer II role works with external suppliers and cross-functional teams on a daily basis to resolve supplier related issues, manage supplier activities within projects, drive continuous improvement while driving key quality metrics across the Supplier Quality Team.
What are the key responsibilities?
• Manage and guide 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.
• Oversee Supplier Approval and Supplier Management Activities for allocated Suppliers to ensure Aerogen Supplier Approval Requirements are met.
• 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, analyse feedback and identify and implement appropriate problem solving and statistical techniques to improve quality of manufactured product and overall effectiveness and efficiency of processes.
• Provide guidance and mentoring of resources within Calibration and Supplier Quality.
• Establish analysis techniques and other quality control tools within project activities as well as utilization of these to solve specific supplier quality problems.
• Overall responsibility for GMP standards and compliance within Aerogen’s Project Teams and Supplier Engagement.
• Maintain compliance with ISO and FDA Quality System regulations.
• The role will also support external audits, internal audits and any relevant Quality/Regulatory compliance related activities as deemed necessary. The role will require a high degree of flexibility to coordinate the variety of tasks.
What education and experience are required?
• BE/BS Degree. A Post-graduate qualification in Quality Assurance is preferable although not mandatory.
• Minimum four years Quality Engineering experience or related role within the medical device industry.
What key skills will make you great at the role?
• 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.
• Ability to liaise with suppliers, customers and regulatory contacts in an informed professional manner.
• Thorough understanding of ISO 13485 and FDA QSR standards.
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.
• ‘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
Check out our careers website to discover more about Life at Aerogen.
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.
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 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.
What is the role?
The Supplier Quality Engineer II role works with external suppliers and cross-functional teams on a daily basis to resolve supplier related issues, manage supplier activities within projects, drive continuous improvement while driving key quality metrics across the Supplier Quality Team.
What are the key responsibilities?
• Manage and guide 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.
• Oversee Supplier Approval and Supplier Management Activities for allocated Suppliers to ensure Aerogen Supplier Approval Requirements are met.
• 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, analyse feedback and identify and implement appropriate problem solving and statistical techniques to improve quality of manufactured product and overall effectiveness and efficiency of processes.
• Provide guidance and mentoring of resources within Calibration and Supplier Quality.
• Establish analysis techniques and other quality control tools within project activities as well as utilization of these to solve specific supplier quality problems.
• Overall responsibility for GMP standards and compliance within Aerogen’s Project Teams and Supplier Engagement.
• Maintain compliance with ISO and FDA Quality System regulations.
• The role will also support external audits, internal audits and any relevant Quality/Regulatory compliance related activities as deemed necessary. The role will require a high degree of flexibility to coordinate the variety of tasks.
What education and experience are required?
• BE/BS Degree. A Post-graduate qualification in Quality Assurance is preferable although not mandatory.
• Minimum four years Quality Engineering experience or related role within the medical device industry.
What key skills will make you great at the role?
• 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.
• Ability to liaise with suppliers, customers and regulatory contacts in an informed professional manner.
• Thorough understanding of ISO 13485 and FDA QSR standards.
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.
• ‘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
Check out our careers website to discover more about Life at Aerogen.
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.
Location
Ireland - Head Office (B2)
Ireland - Head Office (B2)
Department
QA/RA
QA/RA
Job Title
Supplier Quality Engineer II
Supplier Quality Engineer II
Salary
Experience
City
Galway
Galway
Country
Ireland
Ireland
