Quality Engineer I – Post Market Surveillance
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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
This role will support the QRS team in ensuring compliance with MDR and other global regulatory requirements for Aerogen products. This entry-level role provides structured training and mentorship in Post Market Surveillance (PMS) activities including complaint intake investigations support vigilance reporting data trending and preparation of reports such as PSUR inputs. The successful candidate will work closely with senior engineers to develop skills in quality systems regulatory compliance and continuous improvement.
What are the key responsibilities
- Support the intake logging and tracking of product complaints in accordance with regulatory and internal requirements.
- Assist in complaint investigations by gathering data performing basic analysis and preparing documentation under supervision to drive continuous product and process improvements.
- Supporting post-market surveillance activities to ensure compliance with EN ISO13485:2016 FDA QSR and other applicable regulations.
- Support vigilance reporting activities including preparation of complaint summaries and assisting with submissions to regulatory agencies.
- Compile and analyse PMS metrics (complaints vigilance KPIs trend data) for internal reporting and management reviews.
- Contribute to the preparation of Periodic Safety Update Reports (PSURs) by collating complaint and PMS data.
- Assist with internal and external audit readiness activities relating to PMS.
- Collaborate with cross-functional teams to support trending risk analysis and improvement initiatives.
- Participate in team meetings quality system projects and training opportunities to build knowledge of PMS and QMS processes.
- Fulfill other duties assigned by the Senior Quality Engineer Post Market Surveillance or line manager.
What education and experience are required
- A Level 8 degree in Life Sciences Engineering or related discipline.
- 1-3 years of prior experience required.
- Strong attention to detail analytical skills and willingness to learn.
- Proficient in Microsoft Office (Excel Word PowerPoint).
- Effective communicator both written and verbal with the ability to collaborate across teams.
What key skills will make you great at the role
- Interest in developing expertise in Post Market Surveillance and Quality Systems.
- Ability to work methodically and document tasks accurately.
- Strong organisational skills and commitment to meeting deadlines.
- Openness to training feedback and continuous learning in a regulated environment.
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. Theres 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.
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 emailprotected. Please include your name and preferred method of contact.
Key Skills
- Microsoft Access
- SQL
- Analysis Skills
- Microsoft Powerpoint
- Securities Law
- Data Mining
- Investment Banking
- Market Research
- Microsoft Excel
- Visual Basic
- Bloomberg
- Data Analysis Skills
