LSC have a great contract opportunity for a Quality Engineer to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
If you have minimum 4 years’ experience in a highly regulated environment and are ready for your next challenge, this could be the perfect project for you!
KEY RESPOSIBILITIES ABOUT THE ROLE:
o Working with key stakeholders and within the QMS team, play a pivotal role in leading relevant departments in developing and implementing a Quality Management System based around ISO 13485, 21CFRPart4, and EUMDR.
o Be the Subject Matter Expert regarding Acceptable Quality Standards for processes.
o Support the company by helping review and approve necessary Procedures, Work Instructions, Forms and training.
o To help develop a culture of continuous improvement within the Company.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o A degree in a relevant engineering, design or science discipline (or equivalent qualification)
o Appreciation for all stakeholders involved in new product development
o 4+ years’ experience in a highly regulated environment
o Developing and improving Quality Management Systems and the ability to interpret regulations
o Experience ensuring a high level of compliance with MDR, ISO 13485, 21 CFR 820, and cGMP
o Experience auditing to ISO 9001 or ISO 13485 would be an advantage
o Experience in product development and the application of Design Controls would be an advantage
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
To apply, submit your CV via this advert or contact Katie Browne at LSC on 021-4777329 if you have anymore questions about this Quality Engineer (QMS) opportunity!