Quality Projects Engineer
- The Quality Engineer is a Project based role & he /she will be responsible for Quality within their prescribed project.
- S/he will primarily be responsible for transfer of production documentation and developing / executing Validation documentation.
- S/he will be working as part of a team to maintain high quality / performance standards on all Creganna Medical products.
- This role includes customer interfacing both internally and externally, which requires a high level of professionalism and responsibility.
- This challenging position will require an ability to work with minimum supervision and ensure compliance to the Creganna Medical Quality System.
- Support Project Manager / Mentor Team Leaders / production teams to achieve business objectives & performance in line with Project goals and KPI’s
- Overall responsibility for production GMP standards and compliance.
- Establishing inspection standards, plans, frequencies and test methods.
- Establish a production process documentation at the receiving site which aligns with sending site controlled process through transfer of all relevant documentation
- Preparing and updating Operations procedures and associated documentation while maintaining compliance with quality standards and customer requirements
- Perform an active role in project planning and risk management from a quality perspective.
- Have a good working knowledge of ISO/FDA/MDD and other Manufacturing related regulatory requirements.
- Maintain relevant documentation to comply with quality standards and customer requirements.
- Development and executing Validation documentation which aligns with the receiving sites Quality system.
- Develop strong links with customer organisation’s and other project stakeholders.
- Supporting customer and surveillance accreditation audits.
- Performing an active role in further development and continuous improvement of the quality management system.
- Other duties as assigned from time to time.
- Degree in Quality or Degree in Science / Engineering.
- Experience within a similar role as quality engineer.
- 5+yrs industry experience in a medical device-manufacturing or pharmaceutical environment.
- Working knowledge of FDA and ISO Quality systems for Medical device companies.
- New product introduction and manufacturing process transfer experience would be a distinct advantage.
- Experience in developing and executing Equipment and Process Validations
- Quality experience in component and device manufacturing desirable.
- Excellent written and oral communication skills essential.
Values: Integrity, Accountability,Teamwork, Innovation
Are you interested?
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Excellent written and oral communication skills essential.