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Quality Engineer II, Post Market Surveillance (PMS)
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 Quality Engineer II, Post Market Surveillance (PMS) will work within the current regulatory environment and frameworks for all relevant markets that Aerogen wishes to market our products. The successful candidate will be responsible for MDR Post Market Surveillance requirements, proactive trending, complaint monitoring and providing updates to the existing technical files. This role also involves review, submission and follow ups for MDR, EU and worldwide vigilance reporting to external regulatory agencies.
What are the key responsibilities?
• Manage complaints, investigations, Vigilance reports with updates as relevant to technical files.
• Responsible for site complaints and Vigilance KPIs
• Manage review, submission and follow ups for MDR, EU and worldwide vigilance issues
• Support Design Assurance in risk management, risk analysis and Health Hazard Analysis associated with complaints and post market surveillance information.
• Support Clinical Affairs in relation to complaints and post market surveillance.
• Perform Complaint Trend analysis and post market surveillance reports for various products.
• Participate in customer and Notified Body audits.
• Participate in internal audits as per internal audit schedule.
• Manage Non-Conformances and CAPA specifically linked to complaints.
• Support continuous improvement initiatives as assigned by the Manager.
• Collaborate with cross-functional team members in collecting, analyzing, trending and reporting on safety and performance data to identify potential adverse safety risks or performance trends.
• Develop specific objectives and manage work assignments, with minimal guidance to achieve objectives in conformance with global regulatory and business goals.
• Collaborate with RA teams to support timely and quality regulatory submissions and approvals globally.
• Fulfill other duties outside of job description as requested by manager.
What education and experience are required?
• A level 8 Life Science or Engineering degree.
• 3+ years of experience.
What key skills will make you great at the role?
• Competent writing skills to address any regulatory issues when reporting to external regulatory agencies.
• Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Powerpoint, Master Control, Adobe, Sharepoint, MS Teams, Outlook, and others as required.
• Maintain knowledge of current FDA, EMA and international regulations/guidelines/policies related to medical devices as applicable to Aerogen’s products and services.
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 Quality Engineer II, Post Market Surveillance (PMS) will work within the current regulatory environment and frameworks for all relevant markets that Aerogen wishes to market our products. The successful candidate will be responsible for MDR Post Market Surveillance requirements, proactive trending, complaint monitoring and providing updates to the existing technical files. This role also involves review, submission and follow ups for MDR, EU and worldwide vigilance reporting to external regulatory agencies.
What are the key responsibilities?
• Manage complaints, investigations, Vigilance reports with updates as relevant to technical files.
• Responsible for site complaints and Vigilance KPIs
• Manage review, submission and follow ups for MDR, EU and worldwide vigilance issues
• Support Design Assurance in risk management, risk analysis and Health Hazard Analysis associated with complaints and post market surveillance information.
• Support Clinical Affairs in relation to complaints and post market surveillance.
• Perform Complaint Trend analysis and post market surveillance reports for various products.
• Participate in customer and Notified Body audits.
• Participate in internal audits as per internal audit schedule.
• Manage Non-Conformances and CAPA specifically linked to complaints.
• Support continuous improvement initiatives as assigned by the Manager.
• Collaborate with cross-functional team members in collecting, analyzing, trending and reporting on safety and performance data to identify potential adverse safety risks or performance trends.
• Develop specific objectives and manage work assignments, with minimal guidance to achieve objectives in conformance with global regulatory and business goals.
• Collaborate with RA teams to support timely and quality regulatory submissions and approvals globally.
• Fulfill other duties outside of job description as requested by manager.
What education and experience are required?
• A level 8 Life Science or Engineering degree.
• 3+ years of experience.
What key skills will make you great at the role?
• Competent writing skills to address any regulatory issues when reporting to external regulatory agencies.
• Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Powerpoint, Master Control, Adobe, Sharepoint, MS Teams, Outlook, and others as required.
• Maintain knowledge of current FDA, EMA and international regulations/guidelines/policies related to medical devices as applicable to Aerogen’s products and services.
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
Quality Engineer II, Post Market Surveillance (PMS)
Quality Engineer II, Post Market Surveillance (PMS)
Salary
Experience
City
Galway
Galway
Country
Ireland
Ireland
