The Principal Quality Engineer is responsible for:
- The co-ordination and control of sterilisation, biocompatibility (finished product and raw materials) and environmental monitoring (including all cleanrooms)
- Responsible for the training of the quality inspectors in relation to sterile release and for overseeing this approval.
- Playing a role in the plant annual objectives.
- Ensure continued compliance with all Regulatory Standards. These includes:
- ISO 11135
- ISO 10993
- ISO 14644
- ISO 14698
- ISO 11607
- ISO 13485
- FDA QSR
- ISO 14000
- Ensuring continued compliance with DMR
- Monitor all aspects of product and paperwork preparation for sterilisation and approval and environmental monitoring in the manufacturing process for compliance to ensure quality product is shipped to customer and provide:
- Trend analysis of data
- Potential improvements for review based on the trends.
- Areas for improvement to senior management.
- Review and propose changes to sampling plans based on trend analysis and
- Ensuring continuous compliance with the following:
- Related sterilisation validation standards.
- Related biocompatibility and environmental standards
- Conduct training in sterilisation and microbiological and related procedures as required.
- Drive the site validation for sterilisation, including all liaisons with the contract steriliser.
- Interacting and presenting sterilisation and microbiological documentation during FDA, NSAI, Corporate and customer audits.
- Carry out a documented monthly evaluation of cleanrooms
- Support any RCA meetings related to sterilisation and /or environmental monitoring to ensure that internal and customer concerns are handled and dealt with in an appropriate manner.
- Review and ensure that area of responsibility documents listed below are approved in an appropriate and timely manner
- Sterilisation and cleanroom Validations.
- Product adoptions to the LRI sterile cycle
- Engineering Change Order (ECO).
- Request for Corrective Action (RCA).
- Request for Technical assistance (RTA)
- Material Review Request (MRR) – must countersign all related to sterilisation and environmental monitoring.
- Internal Audits.
- Failure Mode Effect Analysis (FMEA).
- Variation Permits (VP).
- Work on specialised projects as required.
- Ensure the company behavioral standards are adhered to, setting the example yourself for your direct reports.
- Project meeting attendance as required.
- Attend and participate in daily cell meetings.
- Preparation of information for PMR and Management Review meetings.
- Ensure that in your absence (or absence of any of your reports) your department provides adequate day to day service. Ensure that other departments know of your arrangements well in advance.
- Ensuring backup and notification for any absences within the group, and being able to step down when required based on priorities.
- Work efficiently using own initiative, escalating decisions as, when, and only when, necessary.
- Be an active member of the team and work with all employees to develop a world class lean manufacturing system.
- Ensure the company behavioral standards are adhered to.
- Travel required between Wexford and Galway for the role
SKILLS AND KNOWLEDGE:
- Ability to communicate and work with people inside and outside the department.
- Good communicator (written and oral).
- Ability to train and lead where required.
- Ability to co-ordinate, plan and organise in a timely manner.
- Knowledge of engineering theories and methods, demonstrating an aptitude for analysis and problem solving.
- Rigorous attention to detail.
- Ability to work independently and without direct supervision while maintaining adherence to timelines is fundamental to the role.
MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:
- Engineering or science Degree.
- Qualification in microbiology is preferable
- A Six Sigma qualification will be a distinct advantage.
- Good PC skills
- 1-3 years’ experience in a quality assurance role in the pharmaceutical, healthcare or medical device sector essential, preferably in an FDA regulated environment
PHYSICAL & MENTAL DEMANDS.
- Dealing with Ambiguity.
- Work effectively with close tolerances.
- Conflict Management
- Timely Decision Making
For further information on the Principal Quality Engineer (Microbiologist) obased in Galway /New Ross please contact Orla on 086 0449476 / email@example.com
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