Quality Systems Engineer II (Specified Purpose Contract)
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Job Location:
Monthly Salary:
Posted on:
11 hours 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. Recognized 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 person in this role is responsible for:
- Contribute to key elements of the Quality System to ensure compliance with relevant standards for the business including EN ISO13485:2016 FDA QSR.
- Ensure the quality system is maintained and implemented in a compliant manner Partner with colleagues to identify areas of improvement and implement as required.
- Coordinate and work with all functions in a collaborative manner where quality system compliance is dependent.
What are the key responsibilities
- Participate in the Internal Audit program to ensure that all audits assigned are completed in a thorough and timely manner.
- Coordinate the Non-Conforming and CAPA system to ensure that all NC/CAPAs are completed in a thorough and timely manner.
- Lead with NC/CAPA and planned deviations investigation root cause analysis and corrective action implementation.
- Compile data for monthly quality scorecards and management review in an accurate and timely manner.
- Assist with the implementation and monitoring of eQMS.
- Participate in the preparation and coordination activities for external audits and liaise as required with SMEs to ensure audits are conducted in an efficient manner.
- Create and maintain company documentation such as quality manuals and quality procedures.
- Supports Quality systems training for employees
- Participate in weekly quality meetings and complete tasks assigned.
- Contribute to the Quality System team to help make necessary improvements and changes.
- Other tasks as assigned by the Senior Quality Systems Engineer II
What education and experience are required
- A degree in Engineering Technology or Science:
- At least 3-5 years experience working in a regulated medical device or pharmaceutical company.
- Experience in Non-Conformance and CAPA system.
- Excellent planning and coordination skills.
- Excellent verbal and written communication skills.
- Excellent attention to detail skills.
What key skills will make you great at the role
- Ability to work within a team environment to achieve agreed company goals.
- Ability to communicate quality / regulatory concepts effectively.
- Excellent understanding of ISO 13485:2016 FDA QSR and EU MDR regulations.
- Formal Audit Training
- Proficiency in use of desktop software applications such as MS office.
- Some travel may be required with the role.
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:
- Competitive bonus plan.
- Above market life insurance.
- Opportunities for development and professional growth.
- Aerogen Connect our employee-led program that helps our global teams unite and have fun.
- We donate 1% of profits and time to charities and organizations.
Visit our careers website for more information about life at Aerogen.
Aerogen is committed to promoting diversity inclusion and equality in the workplace. If you have difficulty using our application process please contact us via email at emailprotected. Please provide your name and preferred contact method.
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