Quality Engineer
Life
Sciences Manufacturing
Dublin City
West
CPL recruitment are delighted to assist our client within life sciences manufacturing source a Quality Engineer for their plant in city west. This is a maternity cover role, and you will
be joining the company at an exciting time as they are undertaking significant
expansion and growth.
You will be working for a
well-known and respected global brand in the medical device sector, prior
experience in a regulated environment is desirable.
There is some important information about this hire at the end of the role overview, please read
Key Deliverable:
Support the development, implementation, and oversight of an effective Quality Management System that operates in compliance with corporate quality policies and procedures, and relevant regulatory requirements and industry guidance.
Lead and or support the oversight of product realisation and commercial manufacturing activities, such as product/specification development, tech transfer, validation, process
capability, facilities/utilities/equipment qualification and maintenance, and materials
management.
Key Duties
- Document control and review/approval of controlled documents
- Change management and review of change controls.
- Investigation and CAPA management, including robust root cause
analysis.
- Complaint management and performance of complaint investigations
- Supplier quality management and performance of supplier audits as
appropriate
- Internal audit program and performance of internal audits
- Training program; conduct training when needed.
- Implementation of Quality Risk Management in relevant aspects of
the QMS
- Management Review
- ISO certification and maintenance
Desired Experience
· Ability to think clearly and act decisively when faced with challenges
· Ability to challenge and influence at all levels of the organisation to improve in an
environment when standards are already very high
Important information about this hire;
· Please note this is an 11 month FTC starting in Jan or Feb 25 at the latest.
· Interviews will occur in Dec/Jan
· Completion bonus payable at the end of the contract.
· CPL recruitment will support you if needed to secure another role at the end of this contract.
· Stamp 1G holders are welcome to apply if they have 12 months plus remaining on their current visa.
For more information, reach out
to Aisling Murray [email protected] or call me on 087 4671309.
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